[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Rules and Regulations]
[Pages 71794-71819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27394]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882,
884, 886, 888, 890, and 892
[Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610]
Medical Devices; Exemptions From Premarket Notification for Class
I and Class II Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we)
identified a list of class I devices and class II devices that are now
exempt from premarket notification requirements, subject to certain
limitations. FDA published the lists of final determinations in
accordance with procedures established by the 21st Century Cures Act
(Cures Act). Although each classification regulation for each such type
of device shall be deemed amended to incorporate such exemption, we are
publishing this final order to amend the codified language for each
listed class I and class II device's classification regulation to
reflect the final determinations. FDA's action decreases regulatory
burden on the medical device industry and eliminates private costs and
expenditures required to comply with certain Federal regulations.
DATES: This order is effective December 30, 2019.
FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5502, Silver Spring, MD 20993, 301-796-
9603, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Cures Act (Pub. L. 114-255) was signed into law on December 13,
2016. Under the Cures Act, section 3054 amended section 510(l) and (m)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360(l) and (m)). As amended, section 510(l)(2) of the FD&C Act requires
FDA to identify through publication in the Federal Register, any type
of class I device that the Agency determines no longer requires a
report under section 510(k) of the FD&C Act to provide reasonable
assurance of safety and effectiveness.
[[Page 71795]]
FDA shall publish this determination within 120 days of the date of
enactment of the Cures Act and at least once every 5 years thereafter,
as FDA determines appropriate. Further, section 510(l)(2) provides that
upon the date of publication of the Agency's determination in the
Federal Register, a 510(k) will no longer be required for these devices
and the classification regulation applicable to each such type of
device shall be deemed amended to incorporate such exemption.
As amended, section 510(m)(1)(A) of the FD&C Act provides that,
within 90 days after enactment of the Cures Act and at least once every
5 years thereafter, FDA shall publish in the Federal Register a notice
containing a list of each type of class II device that FDA determines
no longer requires a report under section 510(k) of the FD&C Act to
provide reasonable assurance of safety and effectiveness. This notice
shall provide at least a 60-day comment period. Within 210 days of
enactment of the Cures Act, FDA shall publish in the Federal Register a
list representing its final determination regarding exemption of
devices that were contained in the proposed list published under
510(m)(1)(A) of the FD&C Act. Further, section 510(m)(3) of the FD&C
Act provides that upon the date of publication of the final list in the
Federal Register, a 510(k) will no longer be required for these devices
and the classification regulation applicable to each such device shall
be deemed amended to incorporate such exemption.
In the Federal Register of April 13, 2017 (82 FR 17841), in
accordance with the amendments to 510(l)(2), FDA issued a notice of
final determination to exempt a list of class I devices from premarket
notification requirements under section 510(k) of the FD&C Act, subject
to certain limitations. In the Federal Register of March 14, 2017 (82
FR 13609), in accordance with the amendments to 510(m)(1)(A), FDA
issued a notice proposing to exempt a list of class II devices from
premarket notification requirements under section 510(k) of the FD&C
Act, subject to certain limitations. After a 60-day comment period, in
the Federal Register of July 11, 2017 (82 FR 31976), FDA issued a
notice of final determination to exempt class II devices provided in
the proposed list. Through this action, FDA is now amending the
codified language for each listed classification regulation to reflect
final determinations for these class I and class II exemptions.\1\
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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Following publication of the notices, FDA determined that it is
unnecessary to update three classification regulations (21 CFR
872.4565, 21 CFR 878.4014, and 21 CFR 880.6320) included in the class I
notice, 82 FR 17841. Five product codes corresponding to these three
classification regulations (EGI and EIB (21 CFR 872.4565), OVR (21 CFR
878.4014), KZF and PEQ (21 CFR 880.6320)) were identified for exemption
in 82 FR 17841; however, the corresponding classification regulations
were already class I, exempt from premarket notification procedures in
subpart E of part 807 (21 CFR part 807, subpart E) subject to the
limitations in the corresponding ``.9'' regulations (i.e., 21 CFR
872.9, 21 CFR 878.9 or 21 CFR 880.9); and, therefore, no revisions to
the codified are necessary. Additionally, we determined that it is
unnecessary to update 21 CFR 876.5820 included in the class II notice,
82 FR 13609. The product code within this classification regulation
(FKI) was identified for exemption in 82 FR 13609. However, this device
type is specifically identified within the class I paragraph of this
classification regulation (21 CFR 876.5820(b)(2)) and already exempt
from premarket notification procedures in subpart E of part 807 subject
to the limitations in 21 CFR 876.9. Therefore, no revisions to the
codified are necessary.
We are also making a revision to correct a misidentified
classification regulation in 82 FR 31976. The notice incorrectly listed
the classification regulation 21 CFR 868.1400 ``Carbon dioxide gas
analyzer'' as corresponding with product code LLK; however, the correct
classification regulation associated with product code LLK is 21 CFR
880.5780 ``Medical Support Stocking''. Therefore, 21 CFR 868.1400
remains unchanged, and 21 CFR 880.5780(a)(2) is revised to reflect the
exemption.
We are revising the name of one classification regulation,
currently entitled ``Urological clamp for males'', in response to FDA's
exemption in 82 FR 17841. Part 876.5160 is currently entitled
``Urological clamp for males,'' which was previously exempt from
premarket notification procedures ``. . . Except when intended for
internal use or use on females . . .''. In 82 FR 17841, we exempted
product code MNG, ``External Urethral Occluder, Urinary Incontinence-
Control, Female'' and removed the current limitation language regarding
``use on females.'' Therefore, FDA is revising the name of the
classification regulation to read ``Urological clamp'' to ensure
clarity.
II. Criteria for Exemption
As amended by the Cures Act, section 510(l) now has two provisions,
510(l)(1) and (2). Under 510(1)(1), a class I device is exempt from the
premarket notification requirements under section 510(k) of the FD&C
Act, unless the device is intended for a use which is of substantial
importance in preventing impairment of human health or it presents a
potential unreasonable risk of illness or injury. Based on these
criteria, FDA evaluated all class I devices to determine which device
types should be exempt from premarket notification requirements.
For class II devices, there are a number of factors FDA may
consider to determine whether a 510(k) is necessary to provide
reasonable assurance of the safety and effectiveness of a class II
device. These factors are discussed in the January 21, 1998, Federal
Register notice (63 FR 3142) and subsequently in the guidance we issued
on February 19, 1998, entitled ``Procedures for Class II Device
Exemptions From Premarket Notification, Guidance for Industry and CDRH
Staff ''.\2\
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\2\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.
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III. Limitations on Exemptions
Although FDA exempted the types of class I and class II devices
from the premarket notification requirements under section 510(k) of
the FD&C Act in accordance with the provisions under 510(l) and (m), an
exemption from the requirement of premarket notification does not mean
the device is exempt from any other statutory or regulatory
requirements, unless such exemption is explicitly provided by order or
regulation. FDA's determination that premarket notification is
unnecessary to provide a reasonable assurance of safety and
effectiveness is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
In addition to being subject to the general limitations to the
exemptions found in 21 CFR 862.9 to 892.9, FDA has also partially
limited some exemptions from premarket notification requirements to
specific devices within
[[Page 71796]]
the listed device type. In such situations where a partial exemption
limitation has been identified, FDA has determined that premarket
notification is necessary to provide a reasonable assurance of safety
and effectiveness for these devices.
IV. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Paperwork Reduction Act of 1995
This final order refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
part 807, subpart E, regarding premarket notification submissions, have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR parts 801 and 809, regarding labeling, have been
approved under OMB control number 0910-0485; and the collections of
information in 21 CFR part 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073.
List of Subjects
21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and
890
Medical devices.
21 CFR Part 864
Blood, Medical devices, Packaging and Containers.
21 CFR Part 866
Biologics, Laboratories, Medical devices.
21 CFR Part 886
Medical devices, Ophthalmic goods and services.
21 CFR Part 892
Medical devices, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888,
890, and 892 are amended as follow:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
0
1. The authority citation for part 862 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. In Sec. 862.1020, revise paragraph (b) to read as follows:
Sec. 862.1020 Acid phosphatase (total or prostatic) test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
3. In Sec. 862.1090, revise paragraph (b) to read as follows:
Sec. 862.1090 Angiotensin converting enzyme (A.C.E.) test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
4. In Sec. 862.1100, revise paragraph (b) to read as follows:
Sec. 862.1100 Aspartate amino transferase (AST/SGOT) test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
5. In Sec. 862.1150, revise paragraph (b) to read as follows:
Sec. 862.1150 Calibrator.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
6. In Sec. 862.1345, revise paragraph (b) to read as follows:
Sec. 862.1345 Glucose test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
7. In Sec. 862.1350, revise paragraph (b) introductory text to read as
follows:
Sec. 862.1350 Continuous glucose monitor secondary display.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9. The
special controls for this device are:
* * * * *
0
8. In Sec. 862.1410, revise paragraph (b) to read as follows:
Sec. 862.1410 Iron (non-heme) test system.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
9. In Sec. 862.1415, revise paragraph (b) to read as follows:
Sec. 862.1415 Iron-binding capacity test system.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
10. In Sec. 862.1445, revise paragraph (b) to read as follows:
Sec. 862.1445 Lactate dehydrogenase isoenzymes test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
11. In Sec. 862.1509, revise paragraph (b) to read as follows:
Sec. 862.1509 Methylmalonic acid (nonquantitative) test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
12. In Sec. 862.1580, revise paragraph (b) to read as follows:
Sec. 862.1580 Phosphorous (inorganic) test system.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
13. In Sec. 862.1660, revise paragraph (b) to read as follows:
Sec. 862.1660 Quality control material (assayed and unassayed).
* * * * *
(b) Classification. Class I (general controls). Except when
intended for use in donor screening tests, quality control materials
(assayed and unassayed) are
[[Page 71797]]
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
14. In Sec. 862.1685, revise paragraph (b) as follows:
Sec. 862.1685 Thyroxine-binding globulin test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
15. In Sec. 862.1700, revise paragraph (b) as follows:
Sec. 862.1700 Total thyroxine test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
16. In Sec. 862.1775, revise paragraph (b) to read as follows:
Sec. 862.1775 Uric acid test system.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
17. In Sec. 862.2265, revise paragraph (b) introductory text to read
as follows:
Sec. 862.2265 High throughput genomic sequence analyzer for clinical
use.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9. The
special controls for this device are:
* * * * *
0
18. In Sec. 862.2570, revise paragraph (b) to read as follows:
Sec. 862.2570 Instrumentation for clinical multiplex test systems.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9. The
special control is FDA's guidance document entitled ``Class II Special
Controls Guidance Document: Instrumentation for Clinical Multiplex Test
Systems.'' See Sec. 862.1(d) for the availability of this guidance
document.
0
19. In Sec. 862.3050, revise paragraph (b) to read as follows:
Sec. 862.3050 Breath-alcohol test system.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
20. In Sec. 862.3100, revise paragraph (b) to read as follows:
Sec. 862.3100 Amphetamine test system.
* * * * *
(b) Classification. Class II (special controls). An amphetamine
test system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
21. In Sec. 862.3150, revise paragraph (b) to read as follows:
Sec. 862.3150 Barbiturate test system.
* * * * *
(b) Classification. Class II (special controls). A barbiturate test
system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
22. In Sec. 862.3170, revise paragraph (b) to read as follows:
Sec. 862.3170 Benzodiazepine test system.
* * * * *
(b) Classification. Class II (special controls). A benzodiazepine
test system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
23. In Sec. 862.3200, revise paragraph (b) to read as follows:
Sec. 862.3200 Clinical toxicology calibrator.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
24. In Sec. 862.3220, revise paragraph (b) to read as follows:
Sec. 862.3220 Carbon monoxide test system.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
25. In Sec. 862.3240, revise paragraph (b) to read as follows:
Sec. 862.3240 Cholinesterase test system.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
26. In Sec. 862.3250, revise paragraph (b) to read as follows:
Sec. 862.3250 Cocaine and cocaine metabolite test system.
* * * * *
(b) Classification. Class II (special controls). A cocaine and
cocaine metabolite test system is not exempt if it is intended for any
use other than employment or insurance testing or is intended for
Federal drug testing programs. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 862.9, provided the test system is
intended for employment and insurance testing and includes a statement
in the labeling that the device is intended solely for use in
employment and insurance testing, and does not include devices intended
for Federal drug testing programs (e.g.,
[[Page 71798]]
programs run by the Substance Abuse and Mental Health Services
Administration (SAMHSA), the Department of Transportation (DOT), and
the U.S. military).
0
27. In Sec. 862.3270, revise paragraph (b) to read as follows:
Sec. 862.3270 Codeine test system.
* * * * *
(b) Classification. Class II (special controls). A codeine test
system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
28. In Sec. 862.3280, revise paragraph (b) to read as follows:
Sec. 862.3280 Clinical toxicology control material.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 862.9.
0
29. In Sec. 862.3580, revise paragraph (b) to read as follows:
Sec. 862.3580 Lysergic acid diethylamide (LSD) test system.
* * * * *
(b) Classification. Class II (special controls). A lysergic acid
diethylamide (LSD) test system is not exempt if it is intended for any
use other than employment or insurance testing or is intended for
Federal drug testing programs. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 862.9, provided the test system is
intended for employment and insurance testing and includes a statement
in the labeling that the device is intended solely for use in
employment and insurance testing, and does not include devices intended
for Federal drug testing programs (e.g., programs run by the Substance
Abuse and Mental Health Services Administration (SAMHSA), the
Department of Transportation (DOT), and the U.S. military).
0
30. In Sec. 862.3610, revise paragraph (b) to read as follows:
Sec. 862.3610 Methamphetamine test system.
* * * * *
(b) Classification. Class II (special controls). A methamphetamine
test system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
31. In Sec. 862.3620, revise paragraph (b) to read as follows:
Sec. 862.3620 Methadone test system.
* * * * *
(b) Classification. Class II (special controls). A methadone test
system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
32. In Sec. 862.3630, revise paragraph (b) to read as follows:
Sec. 862.3630 Methaqualone test system.
* * * * *
(b) Classification. Class II (special controls). A methaqualone
test system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
33. In Sec. 862.3640, revise paragraph (b) to read as follows:
Sec. 862.3640 Morphine test system.
* * * * *
(b) Classification. Class II (special controls). A morphine test
system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
34. In Sec. 862.3650, revise paragraph (b) to read as follows:
Sec. 862.3650 Opiate test system.
* * * * *
(b) Classification. Class II (special controls). An opiate test
system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
35. In Sec. 862.3700, revise paragraph (b) to read as follows:
Sec. 862.3700 Propoxyphene test system.
* * * * *
[[Page 71799]]
(b) Classification. Class II (special controls). A propoxyphene
test system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
36. In Sec. 862.3870, revise paragraph (b) to read as follows:
Sec. 862.3870 Cannabinoid test system.
* * * * *
(b) Classification. Class II (special controls). A cannabinoid test
system is not exempt if it is intended for any use other than
employment or insurance testing or is intended for Federal drug testing
programs. The device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 862.9, provided the test system is intended for
employment and insurance testing and includes a statement in the
labeling that the device is intended solely for use in employment and
insurance testing, and does not include devices intended for Federal
drug testing programs (e.g., programs run by the Substance Abuse and
Mental Health Services Administration (SAMHSA), the Department of
Transportation (DOT), and the U.S. military).
0
37. In Sec. 862.3910, revise paragraph (b) to read as follows:
Sec. 862.3910 Tricyclic antidepressant drugs test system.
* * * * *
(b) Classification. Class II (special controls). A tricyclic
antidepressant drugs test system is not exempt if it is intended for
any use other than employment or insurance testing or is intended for
Federal drug testing programs. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 862.9, provided the test system is
intended for employment and insurance testing and includes a statement
in the labeling that the device is intended solely for use in
employment and insurance testing, and does not include devices intended
for Federal drug testing programs (e.g., programs run by the Substance
Abuse and Mental Health Services Administration (SAMHSA), the
Department of Transportation (DOT), and the U.S. military).
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
0
38. The authority citation for part 864 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
39. In Sec. 864.5400, revise paragraph (b) to read as follows:
Sec. 864.5400 Coagulation instrument.
* * * * *
(b) Classification. Class II (special controls). A fibrometer or
coagulation timer intended for use with a coagulation instrument is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
40. In Sec. 864.5425, revise paragraph (b) to read as follows:
Sec. 864.5425 Multipurpose system for in vitro coagulation studies.
* * * * *
(b) Classification. Class II (special controls). A control intended
for use with a multipurpose system for in vitro coagulation studies is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
41. In Sec. 864.6550, revise paragraph (b) to read as follows:
Sec. 864.6550 Occult blood test.
* * * * *
(b) Classification. Class II (special controls). A control intended
for use with an occult blood test is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 864.9.
0
42. In Sec. 864.7040, revise paragraph (b) to read as follows:
Sec. 864.7040 Adenosine triphosphate release assay.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
43. In Sec. 864.7275, revise paragraph (b) to read as follows:
Sec. 864.7275 Euglobulin lysis time tests.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
44. In Sec. 864.7300, revise paragraph (b) to read as follows:
Sec. 864.7300 Fibrin monomer paracoagulation test.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9. The
special control for this device is FDA's ``In Vitro Diagnostic Fibrin
Monomer Paracoagulation Test.'' See Sec. 864.1(d) for information on
obtaining this document.
0
45. In Sec. 864.7340, revise paragraph (b) to read as follows:
Sec. 864.7340 Fibrinogen determination system.
* * * * *
(b) Classification. Class II (special controls). A control or
fibrinogen standard intended for use with a fibrinogen determination
system is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to the limitations in Sec.
864.9.
0
46. In Sec. 864.7375, revise paragraph (b) to read as follows:
Sec. 864.7375 Glutathione reductase assay.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
47. In Sec. 864.7415, revise paragraph (b) to read as follows:
Sec. 864.7415 Abnormal hemoglobin assay.
* * * * *
(b) Classification. Class II (special controls). A control intended
for use with an abnormal hemoglobin assay is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 864.9.
0
48. In Sec. 864.7455, revise paragraph (b) to read as follows:
Sec. 864.7455 Fetal hemoglobin assay.
* * * * *
(b) Classification. Class II (special controls). A fetal hemoglobin
stain intended for use with a fetal hemoglobin assay is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 864.9.
0
49. In Sec. 864.7500, revise paragraph (b) to read as follows:
[[Page 71800]]
Sec. 864.7500 Whole blood hemoglobin assays.
* * * * *
(b) Classification. Class II (special controls). An acid hematin
intended for use with whole blood hemoglobin assays is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 864.9.
0
50. In Sec. 864.7720, revise paragraph (b) to read as follows:
Sec. 864.7720 Prothrombin consumption test.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
51. In Sec. 864.7735, revise paragraph (b) to read as follows:
Sec. 864.7735 Prothrombin-proconvertin test and thrombotest.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
52. In Sec. 864.8150, revise paragraph (b) to read as follows:
Sec. 864.8150 Calibrator for cell indices.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
53. In Sec. 864.8165, revise paragraph (b) to read as follows:
Sec. 864.8165 Calibrator for hemoglobin or hematocrit measurement.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
54. In Sec. 864.8175, revise paragraph (b) to read as follows:
Sec. 864.8175 Calibrator for platelet counting.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
55. In Sec. 864.8185, revise paragraph (b) to read as follows:
Sec. 864.8185 Calibrator for red cell and white cell counting.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
0
56. In Sec. 864.8625, revise paragraph (b) to read as follows:
Sec. 864.8625 Hematology quality control mixture.
* * * * *
(b) Classification. Class II (special controls). Except when
intended for use in blood components, the device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 864.9.
0
57. In Sec. 864.9400, revise paragraph (b) to read as follows:
Sec. 864.9400 Stabilized enzyme solution.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 864.9.
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
58. The authority citation for part 866 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
59. In Sec. 866.2900, revise paragraph (b) to read as follows:
Sec. 866.2900 Microbiological specimen collection and transport
device.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 866.9.
0
60. In Sec. 866.3395, revise paragraph (b) to read as follows:
Sec. 866.3395 Norovirus serological reagents.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 866.9. The
special control is FDA's guidance document entitled ``Class II Special
Controls Guidance Document: Norovirus Serological Reagents.'' See Sec.
866.1(e) for the availability of this guidance document.
0
61. In Sec. 866.5210, revise paragraph (b) to read as follows:
Sec. 866.5210 Ceruloplasmin immunological test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 866.9.
0
62. In Sec. 866.5470, revise paragraph (b) to read as follows:
Sec. 866.5470 Hemoglobin immunological test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 866.9.
0
63. In Sec. 866.5620, revise paragraph (b) to read as follows:
Sec. 866.5620 Alpha-2-macroglobulin immunological test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 866.9.
0
64. In Sec. 866.5630, revise paragraph (b) to read as follows:
Sec. 866.5630 Beta-2-microglobulin immunological test system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 866.9.
0
65. In Sec. 866.5750, revise paragraph (b) to read as follows:
Sec. 866.5750 Radioallergosorbent (RAST) immunological test system.
* * * * *
(b) Classification. Class II (special controls). The device, when
intended to detect any of the allergens included in Table 1 in this
paragraph, is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 866.9.
[[Page 71801]]
Table 1--Class II Exempt Allergens Under Sec. 866.5750--
Radioallergosorbent (RAST) Immunological Test Systems
------------------------------------------------------------------------
Source
Allergen code Allergen product (taxonomical name)
------------------------------------------------------------------------
Grass Pollens
------------------------------------------------------------------------
g1.............................. Sweet vernal grass Anthoxanthum
odoratum.
g3.............................. Cocksfoot grass, Dactylis
Orchard grass. glomerata.
g4.............................. Meadow fescue..... Festuca elatior.
g5.............................. Rye-grass Lolium perenne.
(perennial rye
grass).
g7.............................. Common reed Phragmites
(common reed communis.
grass).
g8.............................. Meadow grass, Poa pratensis.
Kentucky blue
(June grass).
g9.............................. Redtop, Bentgrass. Agrostis
stolonifera,
Agrostis gigantea
(Agrostis alba).
g11............................. Brome grass....... Bromus inermis.
g12............................. Cultivated rye Secale cereale.
(cultivated rye
grass).
g13............................. Velvet grass...... Holcus lanatus.
g14............................. Cultivated oat Avena sativa.
(cultivated oat
grass).
g15............................. Cultivated wheat Triticum aestivum
(cultivated wheat (Triticum spp.).
grass).
g16............................. Meadow foxtail Alopecurus
(meadow foxtail pratensis.
grass).
g17............................. Bahia grass....... Paspalum notatum.
g24............................. Wheat grass, Agropyron smithii
Western. (Elymus smithii).
g30............................. Bluegrass, annual. Poa annua.
g70............................. Wild rye grass.... Elymus triticoides
Elymus
condensatus.
g71............................. Canary grass...... Phalaris
arundinacea.
g201............................ Barley, cultivated Hordeum vulgare.
g202............................ Maize, corn Zea mays.
(cultivated corn).
g203............................ Salt grass........ Distichlis
spicata.
g204............................ False oat-grass... Arrhenatherum
elatius.
g216............................ Cyn d 1........... Cynodon dactylon.
g701............................ Phl p 1.0102, Phl Phleum pratense.
p 5.0101.
g702............................ Phl p 7.0101...... Phleum pratense.
g703............................ Phl p 12.0101..... Phleum pratense.
------------------------------------------------------------------------
Weed Pollens
------------------------------------------------------------------------
w2.............................. Western ragweed... Ambrosia
psilostachya.
w4.............................. False ragweed..... Ambrosia
acanthicarpa
(Franseria
acanthicarpa).
w5.............................. Wormwood.......... Artemisia
absinthium
Artemisia annua.
w6.............................. Mugwort........... Artemisia
vulgaris.
w7.............................. Marguerite, ox-eye Chrysanthemum
daisy. leucanthemum.
w8.............................. Dandelion......... Taraxacum vulgare,
Taraxacum
officinale.
w9.............................. Plantain Plantago
(English), lanceolata.
Ribwort.
w10............................. Goosefoot, lamb's Chenopodium album.
quarters.
w11............................. Saltwort Salsola kali
(prickly), (Salsola
Russian thistle. pestifer).
w12............................. Goldenrod......... Solidago virgaurea
(Solidago spp.).
w13............................. Cocklebur, common. Xanthium commune.
w14............................. Common pigweed Amaranthus
(rough pigweed). retroflexus.
w15............................. Scale, Lenscale... Atriplex
lentiformis.
w16............................. Rough marsh elder. Iva ciliate, Iva
annua.
w17............................. Firebush (Kochia). Kochia scoparia.
w18............................. Sheep sorrel...... Rumex acetosella.
w19............................. Wall pellitory.... Parietaria
officinalis.
w20............................. Nettle (Common Urtica dioica.
stinging nettle).
w21............................. Wall pellitory.... Parietaria
judaica.
w22............................. Japanese hop Humulus japonicas
(careless weed). (Humulus
scandens).
w23............................. Yellow dock, Rumex crispus.
Yellow dockweed.
w24............................. Spiny pigweed..... Amaranthus
spinosus.
w27............................. Carnation......... Dianthus spp.
w28............................. Rose.............. Rosa rugosa.
w33............................. Clover............ Trifolium
pratense.
w35............................. Mexican tea....... Chenopodium
ambrosioides.
w36............................. Rabbit bush....... Ambrosia deltoidea
(Franseria
deltoides).
w37............................. Salt bush, annual. Atriplex wrightii.
w39............................. Water hemp, Amaranthus rudis
Western. (Acnida
tamariscina).
w41............................. Burrobrush........ Hymenoclea
salsola.
w42............................. Poverty weed...... Baccharis
neglecta.
w43............................. Common sagebrush.. Artemisia
tridentata.
w45............................. Alfalfa........... Medicago sativa.
w46............................. Dog fennel........ Eupatorium
capillifolium.
w53............................. Geranium.......... Geranium spp.
w67............................. Groundsel bush.... Baccharis
halimifolia.
w69............................. Iodine bush....... Allenrolfea
occidentalis.
w70............................. Ragweed, slender.. Ambrosia
confertiflora.
w75............................. Wing scale Atriplex
(wingscale). canescens.
[[Page 71802]]
w82............................. Careless weed..... Amaranthus
palmeri,
Amaranthus
hybridus.
w90............................. Japanese hop...... Humulus japonicas
(Humulus
scandens).
w203............................ Rape (rape pollen) Brassica napus.
w204............................ Sunflower......... Helianthus annuus.
w206............................ Camomile.......... Matricaria
chamomilla.
w207............................ Lupin............. Lupinus spp.
w210............................ Sugar-beet........ Beta vulgaris.
w211............................ Par j 2.0101...... Parietaria
judaica.
w231............................ Art v 1........... Artemisia vulgaris
(Mugwort).
w232............................ Sal k 1........... Salsola kali.
w233............................ Art v 3........... Artemisa vulgaris
(LTP, Mugwort).
w234............................ Pla l 1........... Plantago
lanceolata.
w235............................ Che a 1.0101...... Chenopodium album.
w236............................ Mer a 1.0101...... Mercurialis annua.
a753............................ Art v 1........... Artemisia vulgaris
(Mugwort weed).
------------------------------------------------------------------------
Tree Pollens
------------------------------------------------------------------------
t1.............................. Box-elder (Maple). Acer negundo, Acer
saccharum.
t2.............................. Gray alder, Alnus incana.
speckled alder
(alder).
t4.............................. Hazel, hazelnut... Corylus avellana,
Corylus
americana.
t5.............................. American beech Fagus grandifolia
(beech). (Fagus
americana).
t6.............................. Mountain juniper, Juniperus ashei
Mountain cedar. (Juniperus
sabinoides).
t8.............................. Elm............... Ulmus americana.
t9.............................. Olive............. Olea europaea.
t10............................. Walnut............ Juglans
californica,
Juglans nigra.
t11............................. Maple leaf Platanus
sycamore, London acerifolia.
plane, Plane tree.
t61............................. Sycamore.......... Platanus
occidentalis.
t12............................. Willow............ Salix caprea,
Salix nigra.
t14............................. Cottonwood Populus deltoides.
(Eastern
Cottonwood/Black
Cottonwood).
t15............................. White ash......... Fraxinus
americana.
t16............................. White pine........ Pinus strobus.
t18............................. Eucalyptus, gum- Eucalyptus
tree. globulus
(Eucalyptus
spp.).
t19/t26......................... Acacia............ Acacia longifolia
(Acacia spp.).
t20............................. Mesquite.......... Prosopis
glandulosa/
Prosopis
juliflora.
t21............................. Melaleuca, cajeput Melaleuca
tree. quinquenervia
(Melaleuca
leucadendron).
t22............................. Pecan, hickory.... Carya
illinoinensis
(Carya pecan).
t23............................. Italian/ Cupressus
Mediterranean/ sempervirens.
funeral cypress.
t24............................. Japanese cypress.. Chamaecyparis
obtusa
(Chamaecyparis
spp.).
t25............................. Ash............... Fraxinus
excelsior.
t27............................. Maple, red........ Acer rubrum.
t29............................. Acacia............ Acacia spp.
t30............................. Birch, white...... Betula
populifolia.
t32............................. Willow, black..... Salix nigra.
t33............................. Ash, Arizona...... Fraxinus velutina.
t35............................. Cedar, salt....... Tamarix gallica.
t37............................. Bald cypress Taxodium
(white bald distichum.
cypress).
t38............................. Elm, Chinese/ Ulmus pumila.
Siberian.
t40............................. Hazelnut tree..... Corylus americana.
t41............................. White hickory..... Carya alba (Carya
tomentosa).
t42............................. Oak, red.......... Quercus rubra.
t43............................. Loblolly pine..... Pinus taeda.
t44............................. Hackberry......... Celtis
occidentalis.
t45............................. Cedar elm......... Ulmus crassifolia.
t47............................. Juniper, one seed. Juniperus
monosperma.
t48............................. Pine, lodgepole... Pinus contorta.
t49............................. Pine, ponderosa... Pinus ponderosa.
t50............................. Beech, European... Fagus sylvatica.
t51............................. Tree of Heaven.... Ailanthus
altissima.
t52............................. Western white pine Pinus monticola.
t54............................. Russian olive..... Elaeagnus
angustifolia.
t55............................. Scotch broom...... Cytisus scoparius.
t56............................. Bayberry.......... Myrica cerifera.
t57............................. Red cedar......... Juniperus
virginiana.
t60............................. Western juniper... Juniperus
occidentalis.
t61............................. Sycamore.......... Platanus
occidentalis.
t70............................. Mulberry (white Morus alba.
mulberry).
t71............................. Red mulberry...... Morus rubra.
t72............................. Queen palm........ Arecastrum
romanzoffiamon.
t73............................. Australian pine... Casuarina
equisetifolia.
[[Page 71803]]
t77............................. Oak mix (red, Quercus spp.
white, black).
t80............................. Japanese cypress.. Chamaecyparis
obtusa.
t81............................. Japanese alder.... Alnus japonica.
t83............................. Mango tree........ Mangifera indica.
t90............................. Walnut, black..... Juglans nigra.
t96............................. Poplar, white Populus alba.
(poplar).
t103/t218....................... Virginia live oak Quercus
(live oak). virginiana.
t105............................ Pepper tree....... Schinus molle.
t110............................ Orange tree....... Citrus sinensis.
t201............................ Spruce, Norway Picea abies (Picea
spruce. excelsa).
t202............................ Alder, smooth..... Alnus incana spp.
Rugosa (Alnus
rugosa).
t203............................ Horse chestnut.... Aesculus
hippocastanum.
t205............................ Elder............. Sambucus nigra.
t206............................ Chestnut.......... Castanea sativa.
t207............................ Douglas fir....... Pseudotsuga
menziesii
(Pseudotsuga
taxifolia).
t208............................ Linden............ Tilia cordata.
t209............................ Horn beam......... Carpinus betulus.
t210............................ Privet............ Ligustrum vulgare.
t211............................ Sweet gum......... Liquidambar
styraciflua.
t212............................ Cedar............. Libocedrus
decurrens.
t213............................ Pine.............. Pinus radiata.
t214............................ Date palm......... Phoenix
canariensis.
t215............................ Lilac............. Syringa vulgaris.
t217............................ Pepper tree....... Schinus molle.
t217............................ Red alder......... Alnus rubra.
t218............................ Virginia live oak. Quercus
virginiana.
t218............................ Bayberry (bayberry/ Myrica gale.
sweet gale).
t219............................ Palo verde........ Cercidium
floridum.
t219............................ Red cedar......... Juniperus
virginiana.
t220............................ Bet v 4........... Betula verrucosa
(Birch).
t221............................ Bet v 2.0101, Bet Betula verrucosa
v 4. (Birch).
t222............................ Cypress (Arizona Cupressus
cypress). arizonica.
t223............................ Oil palm.......... Elaeis guineensis.
t224............................ Ole e 1........... Olea europaea.
t225............................ Bet v 6........... Betula verrucosa
(Birch).
t226............................ Cup a 1........... Cupressus
arizonica.
t227............................ Ole e 7........... Olea Europaea.
t228............................ Aspen, quaking.... Populus
tremuloides.
t229............................ Eastern hemlock... Tsuga canadensis.
t230............................ Redwood (sequoia). Sequoia
sempervirens.
t232............................ Pussy willow...... Salix discolor.
t240............................ Ole e 9.0101...... Olea Europaea.
t241............................ Pla a 1.0101...... Platanus
acerifolia.
t242............................ Pla a 2........... Platanus
acerifolia.
t243............................ Pla a 3.0101...... Platanus
acerifolia.
t244............................ Cor a 1.0103...... Corylus avellana.
t245............................ Aln g 1.0101...... Alnus glutinosa.
t246............................ Cry j 1........... Cryptomeria
japonica.
t280............................ Locust tree....... Robinia
pseudoacacia.
t401............................ Brazilian Schinus
peppertree. terebinthifolius.
t402............................ Mastic tree....... Pistacia
lentiscus.
t404............................ Tree of heaven.... Ailanthus
altissima.
t406............................ Date palm......... Phoenix
dactylifera.
a482............................ Ole e 1........... Olea europaea
(Olive Oil).
------------------------------------------------------------------------
Mites
------------------------------------------------------------------------
d207............................ Blo t 5.0101...... Blomia tropicalis.
d208............................ Lep d 2.0101...... Lepidoglyphus
destructor.
------------------------------------------------------------------------
Microorganisms, Molds, Yeast
------------------------------------------------------------------------
m1.............................. Penicillium Penicillium
chrysogenum chrysogenum
(Penicillium (Penicillium
notatum). notatum).
m2.............................. Cladosporium Cladosporium
herbarum herbarum
(Hormodendrum). (Hormodendrum).
m3.............................. Aspergillus Aspergillus
fumigatus. fumigatus.
m4.............................. Mucor racemosus... Mucor racemosus.
m5.............................. Candida albicans.. Candida albicans.
m7.............................. Botrytis cinerea.. Botrytis cinerea.
m8.............................. Drechslera halodes Drechslera halodes
(Setomelanomma (Setomelanomma
rostrata, rostrata,
Helminthosporium Helminthosporium
halodes, halodes.
Helminthosporium
interseminatum).
[[Page 71804]]
m9.............................. Fusarium Fusarium
moniliforme moniliforme
(Fusarium (Fusarium
proliferatum). proliferatum).
m10............................. Stemphylium Stemphylium
botryosum. herbarum
(Stemphylium
botryosum).
m11............................. Rhizopus nigricans Rhizopus
nigricans.
m12............................. Aureobasidium Aureobasidium
pullulans. pullulans.
m13............................. Phoma betae....... Phoma betae.
m14............................. Epicoccum Epicoccum
purpurascens. purpurascens
(Epicoccum
nigrum).
m15............................. Trichoderma viride Trichoderma
viride.
m16............................. Curvularia lunata. Curvularia lunata,
Curvularia
specifera
(K923044).
m17............................. Cladosporium Cladosporium
fulvum. fulvum.
m18............................. Fusarium culmorum. Fusarium culmorum.
m19............................. Aspergillus Aspergillus
versicolor. versicolor.
m20............................. Mucor mucedo...... Mucor mucedo.
m21............................. Aspergillus Aspergillus
clavatus. clavatus.
m22............................. Micropolyspora Saccharopolyspora
faeni. rectivirgula
(Micropolyspora
faeni).
m23............................. Thermoactinomyces Thermoactinomyces
vulgaris. vulgaris.
m24............................. Stachybotrys atra. Stachybotrys
chartarum
(Stachybotrys
atra).
m24............................. Paecilomyces spp.. Paecilomyces spp.
m25............................. Aspergillus Aspergillus
versicolor. versicolor.
m25............................. Penicillium Penicillium
brevicompactum. brevicompactum.
m26............................. Cladosporium Cladosporium
cladosporioides. cladosporioides.
m26............................. Penicillium Penicillium
citrinum. citrinum.
m27............................. Penicillium spp... Penicillium spp.
m29............................. Aspergillus repens Aspergillus
repens.
m30............................. Penicillium Penicillium
roqueforti. roqueforti.
m32............................. Cladosporium Cladosporium
cladosporioides. cladosporioides.
m34............................. Serpula lacrymans. Serpula lacrymans.
m36............................. Aspergillus Aspergillus
terreus. terreus.
m37............................. Trichophyton Trichophyton
mentagrophytes. mentagrophytes.
m40............................. Aspergillus Aspergillus
amstelodami. amstelodami.
m43............................. Saccharomyces Saccharomyces
Carlsberg. carlsbergensis.
m44............................. Saccharomyces Saccharomyces
cerevisiae. cerevisiae.
m45............................. Hormodendrum Hormodendrum
hordei. hordei.
m46............................. Bipolaris Bipolaris
spicifera. spicifera.
m47............................. Aspergillus Aspergillus
nidulans. nidulans.
m48............................. Aspergillus oryzae Aspergillus
oryzae.
m49............................. Fusarium oxysporum Fusarium
oxysporum.
m50............................. Micropolyspora Saccharopolyspora
faeni. rectivirgula
(Micropolyspora
faeni).
m51............................. Thermoactinomyces Thermoactinomyces
vulgaris. vulgaris.
m53............................. Microspora canis.. Microsporum canis
(Microspora
canis).
m54............................. Aspergillus flavus Aspergillus
flavus.
m63............................. Helminthosporium Helminthosporium
intersemin. intersemin.
m66............................. Mucor plumbeus.... Mucor plumbeus.
m67............................. Mycogone.......... Mycogone
perniciosa.
m68............................. Nigrospora oryzae. Nigrospora oryzae.
m69............................. Rhodotorula....... Rhodotorula rubra
(Rhodotorula
mucilaginosa).
m70............................. Malassezia furfur Malassezia furfur
(Pityrosporum (Pityrosporum
orbiculare). orbiculare).
m71............................. Spondylocladium... Spondylocladium
spp.
m72............................. Epidermophyton.... Epidermophyton
floccosum.
m73............................. Epicoccum nigrum.. Epicoccum
purpurascens
(Epicoccum
nigrum).
m80............................. Staphylococcal Staphylococcus
enterotoxin A aureus.
(Sta a SEA).
m80............................. Helminthosporium Helminthosporium
spp. spp.
m81............................. Staphylococcal Staphylococcus
enterotoxin B aureus.
(Sta a SEB).
m88............................. Stemphylium solani Stemphylium
solani.
m93............................. Gliocladium Gliocladium
fimbriatum. fimbriatum.
m94............................. Phycomyces Phycomyces
blakesleeanus. blakesleeanus.
m201............................ Tilletia tritici Tilletia tritici
(Ustilago nuda, (Ustilago nuda,
Ustilago tritici) Ustilago
(Barley smut). tritici).
m202............................ Acremonium Acremonium
kiliense kiliense
(Cephalosporium (Cephalosporium
acremonium). acremonium).
m203............................ Trichosporon Trichosporon
pullulans. pullulans.
m204............................ Ulocladium Ulocladium
chartarum. chartarum.
m205............................ Trichophyton Trichophyton
rubrum. rubrum.
m207............................ Aspergillus niger. Aspergillus niger.
m208............................ Chaetomium Chaetomium
globosum. globosum.
m209............................ Penicillium Penicillium
frequentans. glabrum
(Penicillium
frequentans).
m209............................ Stachybotrys Stachybotrys
chartarum. chartarum
(Stachybotrys
atra).
m210............................ Trichophyton Trichophyton
mentagrophytes mentagrophytes
var. goetzii. var. goetzii.
m211............................ Trichophyton Trichophyton
mentagrophytes mentagrophytes
var. var.
interdigitale. interdigitale.
m211............................ Oat smut.......... Ustilago avenae.
m212............................ Micropolyspora Saccharopolyspora
faeni. rectivirgula
(Micropolyspora
faeni).
m212............................ Geotrichum Geotrichum
candidum. candidum.
m213............................ Bermuda grass smut Ustilago
cynodontis.
[[Page 71805]]
m214............................ Johnson grass smut Sphacelotheca
cruenta.
m215............................ Corn smut......... Ustilago maydis.
m218............................ Asp f 1.0101...... Aspergillus
fumigatus.
a3050........................... Asp r 1........... Aspergillus
restrictus.
m219............................ Asp f 2........... Aspergillus
fumigatus.
m220............................ Asp f 3.0101...... Aspergillus
fumigatus.
m221............................ Asp f 4........... Aspergillus
fumigatus.
m222............................ Asp f 6.0101...... Aspergillus
fumigatus.
m223............................ Staphylococcal Staphylococcus
enterotoxin C aureus.
(Sta a SEC).
m224............................ Staphylococcal Staphylococcus
enterotoxin D aureus.
(Sta a SED).
m226............................ Staphylococcal Staphylococcus
enterotoxin TSST aureus.
(Sta a TSST).
m227............................ Malassezia spp. Malassezia spp.
(Pityrosporum (Pityrosporum
spp.). spp.).
m228............................ Aspergillus
flavus..
m229............................ Alt a 1.0101...... Alternaria
alternata
(Alternaria
tenuis).
m230............................ Alt a 6.0101...... Alternaria
alternata
(Alternaria
tenuis).
m231............................ Cla h 8.0101...... Cladosporium
herbarum
(Hormodendrum).
m300............................ Eurotium spp...... Eurotium spp.
m304............................ Aspergillus oryzae Aspergillus
oryzae.
m305............................ Penicillium Penicillium
brevicompactum. brevicompactum.
m309............................ Aspergillus Aspergillus
terreus. terreus.
m310............................ Aspergillus Aspergillus
nidulans. nidulans.
m311............................ Aspergillus flavus Aspergillus
flavus.
m312............................ Aspergillus Aspergillus
clavatus. clavatus.
------------------------------------------------------------------------
Epidermal & Animal
------------------------------------------------------------------------
e6.............................. Guinea pig Cavia porcellus.
epithelium.
e7.............................. Pigeon droppings.. Columba palumbus,
Columba livia.
e25............................. Chicken serum..... Gallus domesticus
(Gallus gallus
domesticus;
Gallus spp.).
e26............................. Parrot serum...... Psittacoidea spp.
e62............................. Camel............. Camelus
dromedaries.
e70............................. Goose feathers.... Anser anser.
e71............................. Mouse epithelium.. Mus musculus (Mus
spp.).
e73............................. Rat epithelium.... Rattus norvegicus.
e74............................. Rat urine proteins Rattus norvegicus,
Rattus rattus.
e75............................. Rat serum proteins Rattus norvegicus,
Rattus rattus.
e76............................. Mouse serum Mus musculus (Mus
proteins. spp.).
e77............................. Budgerigar Melopsittacus
droppings. undulatus.
e78............................. Budgerigar Melopsittacus
feathers. undulatus.
e79............................. Budgerigar serum Melopsittacus
proteins. undulatus.
e80............................. Goat epithelium... Capra hircus.
e81............................. Sheep epithelium.. Ovis aries (Ovis
spp.).
e82............................. Rabbit epithelium. Oryctolagus
cuniculus
(Oryctolagus
spp.).
e83............................. Swine epithelium.. Sus scrofa (Sus
scrofa
domesticus; Sus
spp.).
e84............................. Hamster epithelium Cricetus cricetus,
Mesocricetus
auratus, and
Phodopus
sungorus.
e85............................. Chicken feathers.. Gallus domesticus
(Gallus gallus
domesticus;
Gallus spp.).
e86............................. Duck feathers..... Anas
platyrhynchos.
e87............................. Rat epithelium, Rattus norvegicus
serum proteins, Rattus rattus.
and urine
proteins.
e88............................. Mouse epithelium, Mus musculus (Mus
serum proteins, spp.).
and urine
proteins (mouse).
e89............................. Turkey feathers... Meleagris
gallopavo.
e90............................. Budgerigar serum Melopsittacus
proteins, undulatus.
feathers, and
droppings.
e91............................. Pigeon serum Streptopelia
proteins, roseogrisea,
feathers, and Psittacidae spp.
droppings.
e92............................. Parrot serum Ara spp.
proteins,
feathers, and
droppings.
e93............................. Pigeon serum Streptopelia
proteins. roseogrisea.
e94............................. Fel d 1.0101...... Felis domesticus.
a345............................ Fel d 1........... Felis domesticus.
e98............................. Parrot droppings.. Psittacoidea spp.
e101............................ Can f 1.0101...... Canis familiaris
(Canis
domesticus).
a174............................ Can f 1........... Canis familiaris
(Canis
domesticus).
e102............................ Can f 2.0101...... Canis familiaris
(Canis
domesticus).
e196............................ Parakeet feathers. Nymphicus
hollandicus.
e197............................ Parakeet droppings Nymphicus
hollandicus.
e198............................ Parakeet serum.... Nymphicus
hollandicus.
e199............................ Canary bird serum. Serinus canarius.
e200............................ Canary bird Serinus canarius.
droppings.
e201............................ Canary bird Serinus canarius.
feathers (Canary
feathers).
e202............................ Reindeer Rangifer tarandus.
epithelium.
e203............................ Mink epithelium... Mustela spp.
[[Page 71806]]
e204............................ Bos d 6........... Bos domesticus
(Bos taurus; Bos
spp.).
e205............................ Horse, serum Equus caballus
proteins. (Equus spp.).
e206............................ Rabbit, serum Oryctolagus
proteins. cuniculus
(Oryctolagus
spp.).
e208............................ Chinchilla Chinchilla
epithelium. laniger.
e209............................ Gerbil epithelium. Meriones
unguiculatus.
e210............................ Fox epithelium.... Vulpes vulpes.
e211............................ Rabbit, urine Oryctolagus
proteins. cuniculus
(Oryctolagus
spp.).
e212............................ Swine, urine Sus scrofa (Sus
proteins. scrofa
domesticus; Sus
spp.).
e213............................ Parrot feathers... Ara spp.
e214............................ Finch feathers.... Lonchura
domestica.
e215............................ Pigeon feathers... Streptopelia
roseogrisea
(Streptopelia
spp.), Columbia
spp.
e216............................ Deer epithelium... Dama dama.
e217............................ Ferret epithelium. Mustela putorius.
e218............................ Chicken droppings. Gallus domesticus
(Gallus gallus
domesticus;
Gallus spp.).
e219............................ Chicken, serum Gallus domesticus
proteins. (Gallus gallus
domesticus;
Gallus spp.).
e220............................ Fel d 2, Cat serum Felis domesticus.
albumin.
e221............................ Can f 3........... Canis familiaris
(Canis
domesticus) (Dog
serum albumin).
e222............................ Swine serum Sus scrofa (Sus
albumin (Sus s scrofa
PSA). domesticus; Sus
spp.).
e225............................ Lovebird feathers. Psittacoidea
agapomis.
e226............................ Can f 5.0101...... Canis familiaris.
e227............................ Equ c 1.0101...... Equus caballus.
e228............................ Fel d 4.0101...... Felis domesticus.
e230............................ Equ c 3........... Equus caballus.
e231............................ Mus m 1........... Mus musculus.
------------------------------------------------------------------------
Food
------------------------------------------------------------------------
f9.............................. Rice.............. Oryza sativa.
f12............................. Pea (green pea)... Pisum sativum.
f15............................. White bean........ Phaseolus
vulgaris.
f19............................. Cayenne pepper.... Capsicum
frutescens
(Capsicum annum).
f21............................. Sugar cane........ Saccharum
officinarum.
f22............................. Raspberry......... Rubus idaeus.
f26............................. Pork.............. Sus scrofa (Sus
scrofa
domesticus; Sus
spp.).
f29............................. Watermelon........ Citrullus lanatus
(Citrullus
vulgaris).
f31............................. Carrot............ Daucus carota.
f32............................. Oyster mushroom... Pleurotus
ostreatus.
f33............................. Orange............ Citrus sinensis.
f35............................. Potato............ Solanum tuberosum.
f43............................. Mother's milk..... Homo sapiens.
f44............................. Strawberry........ Fragaria vesca
(Fragaria spp.).
f45............................. Yeast, baker's.... Saccharomyces
cerevisiae.
f46............................. Pepper, Red....... Capsicum annuum.
f47............................. Garlic............ Allium sativum.
f48............................. Onion............. Allium cepa.
f49............................. Apple............. Malus x domestica
(Malus spp.).
f51............................. Bamboo shoot...... Phyllostachys
pubescens.
f52............................. Cacao/chocolate... Theobroma cacao.
f54............................. Sweet potato...... Ipomoea batatas.
f55............................. Common millet..... Panicum miliaceum.
f56............................. Foxtail millet.... Setaria italica.
f57............................. Japanese millet... Echinochloa crus-
galli.
f58............................. Pacific squid..... Todarodes
pacificus.
f59............................. Octopus........... Octopus vulgaris
(Octopus spp.).
f63............................. Kefir............. NA.
f67............................. Parmesan cheese... NA.
f81............................. Cheese, cheddar NA.
type.
f82............................. Cheese, mold type. NA.
f83............................. Chicken........... Gallus domesticus
(Gallus gallus
domesticus;
Gallus spp.).
f86............................. Parsley........... Petroselinum
crispum.
f87............................. Melon............. Cucumis melo
Cucumis melo +
Citrullus
lanatus.
f88............................. Mutton (lamb)..... Ovis aries (Ovis
spp.).
f90............................. Malt.............. Hordeum vulgare.
f92............................. Banana............ Musa spp.
f93............................. Cacao............. Theobroma cacao.
f94............................. Pear.............. Pyrus communis
(Pyrus spp.).
f97............................. Yam............... Dioscorea spp.
Dioscorea
opposita.
f97............................. Chamomile tea..... Matricaria
chamomilla.
f98............................. Gliadin........... Triticum aestivum
(Triticum spp.).
f102............................ Cantaloupe........ Cucumis melo var.
cantalupensis.
[[Page 71807]]
f105............................ Chocolate......... Theobroma cacao.
f109............................ Cottonseed........ Gossypium
hirsutum.
f110............................ Giant radish...... Raphanus sativus.
f118............................ Zucchini.......... Cucurbita pepo.
f119............................ Radish............ Raphanus sativus.
f120............................ Venison........... Capreolus
capeolus.
f121............................ Pinto bean........ Phaseolus
vulgaris.
f122............................ Cheese, American.. NA.
f127............................ Black-eyed pea.... Vigna unguiculata.
f131............................ Black Olive....... Olea europaea.
f136............................ Red beet.......... Beta vulgaris var.
conditiva.
f139............................ Goat's Cheese..... Capra aegagrus.
f140............................ Bran.............. NA.
f141............................ Corn (vegetables). Zea mays.
f152............................ Green bell pepper. Capsicum annuum.
f155............................ Brewer's yeast.... Saccharomyces
carlsbergensis.
f157............................ Duck.............. Anas domesticus.
f158............................ Goose............. Anser anser.
f160............................ Camembert cheese.. NA.
f162............................ Nectarine......... Prunus persica
var. nucipersica.
f163............................ Kohlrabi.......... Brassica oleracea
var. gongylodes.
f65............................. Perch.............
f166............................ Leek.............. Allium porrum.
f170............................ Cheese NA.
(Switzerland)
(Swiss cheese).
f174............................ Fig............... Ficus carica.
f177............................ Cranberry......... Vaccinium
macrocarpon.
f179............................ Raisin............ Vitis spp.
f182............................ Lima bean......... Phaseolus lunatus.
f198............................ Flaxseed (bruised Linum
grain). usitatissimum.
f199............................ Untreated native Bos domesticus
milk. (Bos taurus; Bos
spp.).
f208............................ Lemon............. Citrus limon.
f209............................ Grapefruit........ Citrus paradisi.
f210............................ Pineapple......... Ananas comosus.
f211............................ Blackberry........ Rubus fruticosus.
f212............................ Mushroom Agaricus hortensis
(champignon). (Agaricus spp.).
f213............................ Rabbit............ Oryctolagus
cuniculus
(Oryctolagus
spp.).
f214............................ Spinach........... Spinacia oleracea.
f215............................ Lettuce........... Lactuca sativa.
f216............................ Cabbage........... Brassica oleracea
var. capitata.
f217............................ Brussels sprouts.. Brassica oleracea
var. gem.
f218............................ Paprika, sweet Capsicum annuum.
pepper.
f219............................ Fennel seed....... Foeniculum
vulgare.
f219............................ Sage.............. Salvia
officinalis.
f220............................ Cinnamon.......... Cinnamomum spp.
f221............................ Coffee............ Coffea spp.
f222............................ Tea............... Camellia sinensis.
f223............................ Green olive....... Olea europaea.
f225............................ Summer squash, Cucurbita pepo.
pumpkin.
f225............................ Pumpkin........... Cucurbita maxima.
f226............................ Pumpkin seed...... Cucurbita pepo.
f227............................ Sugar-beet seed... Beta vulgaris.
f229............................ Safflower Seed.... Carthamus
tinctorius.
f231............................ Milk, boiled...... Bos domesticus
(Bos taurus; Bos
spp.).
f234............................ Vanilla........... Vanilla
planifolia.
f237............................ Apricot........... Prunus armeniaca.
f241............................ Gouda cheese...... NA.
f242............................ Cherry............ Prunus avium.
f244............................ Cucumber.......... Cucumis sativus.
f246............................ Guar, guar gum.... Cyamopsis
tetragonoloba.
f247............................ Honey............. NA.
f248............................ Rosemary.......... Rosmarinus
officinalis.
f254............................ Plaice............ Pleuronectes
platessa.
f255............................ Plum.............. Prunus domestica,
Prunus americana.
f258............................ Squid............. Loligo spp.
f259............................ Grape............. Vitis vinifera
(Vitis spp.).
f260............................ Broccoli.......... Brassica oleracea
var. italica
(Brassica
oleracea var.
cultivar).
f261............................ Asparagus......... Asparagus
officinalis.
f262............................ Aubergine, Solanum melongena.
eggplant.
f263............................ Green pepper...... Piper nigrum,
Capsicum annuum.
[[Page 71808]]
f264............................ Eel............... Anguilla anguilla.
f265............................ Caraway........... Carum carvi.
f265............................ Cumin............. Cuminum cyminum.
f266............................ Mace.............. Myristica
fragrans.
f267............................ Cardamon.......... Elettaria
cardamomum.
f268............................ Clove............. Syzygium
aromaticum.
f269............................ Basil............. Ocimum basilicum.
f270............................ Ginger............ Zingiber
officinale.
f271............................ Anise............. Pimpinella anisum.
f272............................ Tarragon.......... Artemisia
dracunculus.
f273............................ Thyme............. Thymus vulgaris.
f274............................ Marjoram.......... Origanum majorana.
f275............................ Lovage............ Levisticum
officinale.
f276............................ Fennel, fresh..... Foeniculum
vulgare.
f277............................ Dill.............. Anethum
graveolens.
f278............................ Bay leaf.......... Laurus nobilis.
f279............................ Chili pepper...... Capsicum
frutescens.
f280............................ Black pepper...... Piper nigrum.
f281............................ Curry (Santa NA.
Maria).
f282............................ Nutmeg............ Myristica
fragrans.
f283............................ Oregano........... Origanum vulgare.
f284............................ Turkey meat....... Meleagris
gallopavo.
f285............................ Elk/moose meat.... Alces spp.
f286............................ Mare's milk....... Equus caballus
(Equus spp.).
f287............................ Red kidney bean... Phaseolus
vulgaris.
f288............................ Blueberry......... Vaccinium
myrtillus
(Vaccinium spp.).
f289............................ Date.............. Phoenix
dactylifera.
f291............................ Cauliflower....... Brassica oleracea
var. botrytis.
f292............................ Guava............. Psidium guajava.
f293............................ Papaya............ Carica papaya.
f294............................ Passion fruit, Passiflora edulis
Maracuja. (Passiflora
spp.).
f295............................ Carambola......... Averrhoa
carambola.
f296............................ Carob............. Ceratonia siliqua.
f297............................ Gum Arabic........ Acacia senegal
(Acacia spp.).
f298............................ Tragacanth........ Astragalus spp.
f299............................ Sweet chestnut Castanea sativa.
(chestnut).
f300............................ Pinto bean........ Phaseolus spp.
f301............................ Persimmon (kaki Diospyros kaki.
fruit, sharon).
f302............................ Mandarin Citrus reticulata.
(tangerine,
clementine,
satsumas).
f305............................ Fenugreek......... Trigonella foenum-
graecum.
f306............................ Lime.............. Citrus
aurantifolia.
f307............................ Hake.............. Merluccius
merluccius.
f308............................ Sardine (pilchard) Sardina
pilchardus.
f310............................ Blue vetch........ Lathyrus sativus.
f311............................ Megrim............ Lepidorhombus
whiffiagonis.
f315............................ Green bean........ Phaseolus
vulgaris.
f316............................ Rape seed......... Brassica napus.
f317............................ Coriander......... Coriandrum
sativum.
f318............................ Jack fruit........ Artocarpus
heterophyllus.
f319............................ Beetroot.......... Beta vulgaris.
f320............................ Crayfish.......... Astacus astacus.
f321............................ Horse meat........ Equus caballus
(Equus spp.).
f322............................ Red currant....... Ribes sylvestre.
f324............................ Hop (fruit cone).. Humulus lupulus.
f325............................ Saffron........... Colchicum
autumnale.
f328............................ Fig............... Ficus carica.
f329............................ Watermelon........ Citrullus lanatus.
f330............................ Rose hip.......... Rosa spp.
f331............................ Saffron........... Crocus sativus.
f332............................ Mint.............. Mentha piperita.
f333............................ Linseed........... Linum
usitatissimum.
f336............................ Jujube............ Ziziphus jujuba.
f336............................ Wine vinegar...... Vitis vinifera
(Vitis spp.).
f337............................ Sole.............. Solea solea.
f337............................ English sole...... Parophrys vetulus.
f338............................ Wine, white....... Vitis vinifera
(Vitis spp.).
f339............................ Allspice.......... Pimenta dioica.
f339............................ Wine, red......... Vitis vinifera
(Vitis spp.).
f341............................ Cranberry......... Vaccinium
oxycoccus,
Vaccinium
macrocarpon.
f342............................ Olive (black, Olea europaea.
fresh).
[[Page 71809]]
f343............................ Raspberry......... Rubus idaeus.
f344............................ Sage.............. Salvia
officinalis.
f346............................ Chives............ Allium
schoenoprasum.
f347............................ Quinoa............ Chenopodium
quinoa.
f348............................ Litchi............ Litchi chinensis.
f349............................ Chum salmon roe... Oncorhynchus keta.
f358............................ Artichoke......... Cynara scolymus.
f360............................ Yogurt............ NA.
f368............................ Black bass........ Micropterus
dolomieu
(Micropterus
dolomieui).
f374............................ Karaya gum........ Sterculia urens.
f375............................ Horseradish....... Armoracia
rusticana.
f377............................ Maple syrup....... NA.
f379............................ Okra.............. Abelmoschus
esculentus.
f382............................ Beet, sugar....... Beta vulgaris var.
altissima.
f401............................ Loquat............ Eriobotrya
japonica.
f402............................ Fig............... Ficus carica.
f403............................ Brewer's yeast.... Saccharomyces
cerevisiae.
f405............................ Mint.............. Mentha spp.
f406............................ Arugula........... Eruca vesicaria.
------------------------------------------------------------------------
House Dust
------------------------------------------------------------------------
h1.............................. Greer Labs., Inc.. NA.
h2.............................. Hollister-Stier NA.
Labs.
h6.............................. Japan............. NA.
------------------------------------------------------------------------
Venoms & Insects
------------------------------------------------------------------------
i7.............................. Midge............. Chironomus
yoshimatsui.
i8.............................. Moth.............. Bombyx mori,
Heterocera spp.
i47............................. Water flea........ Daphnia spp.
i49............................. Deer fly.......... Chrysops spp.
i51............................. Black ant......... Camponotus
pennsylvanicus.
i54............................. Flea mix (dog/ Ctenocephalides
cat), common flea. spp.
i71............................. Mosquito.......... Aedes communis,
Aedes spp. and
Culex spp.
i72............................. Green nimitti..... Cladotanytarsus
lewisi.
i73............................. Blood worm........ Chironomus thummi,
Chironomusri
parius,
Chironomus spp.
i75............................. European hornet... Vespa crabro.
i76............................. Berlin beetle..... Trogoderma
angustum.
i77............................. European paper Polistes
wasp. dominulus.
i78............................. Fly............... Musca domestica.
i80............................. Bumblebee......... Bombus
pennsylvanicus.
i201............................ Horse bot fly..... Gasterophilus
intestinalis.
i202............................ Grain weevil...... Sitophilus
granarius.
i203............................ Mediterranean Ephestia
flour moth. kuehniella
(Anagasta
kuehniella).
i204............................ Horse fly......... Tabanus spp.
i205............................ Bumblebee......... Bombus terrestris.
i208............................ Api m 1.0101...... Apis mellifera.
a45............................. Api m 1........... Apis mellifera.
i209............................ Ves v 5.0101...... Vespula vulgaris.
a670............................ Ves v 5........... Vespula vulgaris.
i210............................ Pol d 5.0101...... Polistes
dominulus.
i211............................ Ves v 1.0101...... Vespula vulgaris.
i213............................ Api m 4........... Apis mellifera.
i214............................ Api m 2........... Apis mellifera.
i215............................ Api m 3........... Apis mellifera.
i216............................ Api m 5........... Apis mellifera.
i217............................ Api m 10.......... Apis mellifera.
i220............................ Bla g 1.0101...... Blattella
germanica.
i221............................ Bla g 2.0101...... Blattella
germanica.
i222............................ Bla g 5.0101...... Blattella
germanica.
i223............................ Bla g 7........... Blattella
germanica.
a46............................. Api m 2........... Apis mellifera.
------------------------------------------------------------------------
Miscellaneous
------------------------------------------------------------------------
o1.............................. Cotton, crude Gossypium spp.
fibers.
o3.............................. Cotton (treated).. Gossypium spp.
o70............................. Seminal fluid..... Homo sapiens.
o71............................. Staphylococcus Staphylococcus
aureus. aureus.
[[Page 71810]]
o72............................. Pichia pastoris Pichia pastoris.
crude extract
customer specific.
o72............................. Sperm-sediment.... Homo sapiens.
o73............................. Pichia pastoris Pichia pastoris.
crude extr.
vector customer
specific.
o74............................. Pichia pastoris Pichia pastoris.
with vector
customer specific.
o201............................ Tobacco leaf, Nicotiana tabacum.
tobacco dust.
o202............................ Artemia salina, Artemia salina.
fish feed.
o203............................ Tetramin, fish NA.
feed.
o207............................ Daphnia, fish feed Daphnia spp.
o211............................ Mealworm.......... Tenebrio molitor.
o212............................ Streptavidin...... Streptomyces
avidini.
o213............................ MBP (maltose Escherichia coli.
binding protein).
o214............................ CCD; MUXF3 from Ananas comosus.
bromelain.
o72............................. Enterotoxin A (Sta Staphylococcus
a SEA). aureus.
o73............................. Enterotoxin B (Sta Staphylococcus
a SEB). aureus.
------------------------------------------------------------------------
Parasites
------------------------------------------------------------------------
p1.............................. Ascaris........... Ascaris suum.
p2.............................. Echinococcus...... Echinococcus
granulosus.
p3.............................. Schistosoma....... Schistosoma
mansoni.
p4.............................. Anisakis (Herring Anisakis simplex
Worm). (Anisakis spp.).
p5.............................. Toxocara canis.... Toxocara canis.
p10............................. Ani s 3.0101...... Anisakis simplex
(Anisakis spp.).
p11............................. Ani s 1........... Anisakis simplex
(Anisakis spp.).
------------------------------------------------------------------------
Occupational
------------------------------------------------------------------------
k4.............................. Threshing dust.... NA.
k5.............................. Flax.............. NA.
k7.............................. Hay Dust.......... NA.
k8.............................. Hop (hops)........ Humulus lupulus.
k12............................. Grain mill dust... NA.
k14............................. Kapok............. NA.
k20............................. Sheep's wool Ovis aries (Ovis
(treated) (wool). spp.).
k21............................. Sheep's wool Ovis aries (Ovis
(Untreated). spp.).
k23............................. Straw Dust........ NA.
k33............................. Oak............... NA.
k70............................. Green coffee bean. Coffea spp.
k71............................. Castor bean....... Ricinus communis.
k72............................. Ispaghula......... Plantago psyllium/
Plantago ovata.
k73............................. Silk waste........ NA.
k74............................. Silk.............. Bombyx mori.
k75............................. Isocyanate TDI NA.
(Toluene
diisocyanate).
k76............................. Isocyanate MDI NA.
(Diphenylmethane
diisocyanate).
k77............................. Isocyanate HDI NA.
(Hexamethylen
diisocyanate).
k78............................. Ethylene oxide.... NA.
k79............................. Phthalic anhydride NA.
k80............................. Formaldehyde/ NA.
Formalin.
k81............................. Ficus............. Ficus benjamina
(Ficus spp.).
k83............................. Cotton seed....... Gossypium
hirsutum.
k84............................. Sunflower seed.... Helianthus annuus.
k85............................. Chloramin T....... NA.
k86............................. Trimellitic NA.
anhydride, TMA.
k87............................. Asp o 21, alpha- Aspergillus
amylase. oryzae.
k89............................. Orris root........ Iris florentina.
k99............................. HSA (Human Serum Homo sapiens.
Albumin) (Hom s
HSA).
k201............................ Car p 1, Papain... Carica papaya.
k202............................ Ana c 2, Bromelain Ananas comosus.
k204............................ Maxatase.......... Bacillus
licheniformis.
k205............................ Alcalase.......... Bacillus spp.
k206............................ Savinase, Protease Bacillus spp.
1 (Bac l
Subtilisin).
k208............................ Gal d 4, Lysozyme. Gallus domesticus
(Gallus gallus
domesticus;
Gallus spp.).
k209............................ Hexahydrophtalic NA.
anhydrid.
k210............................ Maleic anhydride.. NA.
k211............................ Methyltetrahydroph NA.
talic anhydrid.
k212............................ Abachi wood dust.. Triplochiton
scleroxylon.
k213............................ Pepsin (Sus s Sus scrofa (Sus
Pepsin). scrofa
domesticus; Sus
spp.).
k213............................ TCPA.............. NA.
k214............................ Bougainvillea..... Bougainvillea spp.
k225............................ Horse radish Armoracia
peroxidase (Arm r rusticana.
HRP).
[[Page 71811]]
k226............................ Ascorbate oxidase Cucurbita pepo.
(Cuc p ascorbate
oxidase).
k301............................ Flour dust........ Triticum spp.
k501............................ Savinase customer Proprietary
specific. knowledge of
customer.
k502............................ Lipolase customer Proprietary
specific. knowledge of
customer.
k503............................ Termamyl customer Proprietary
specific. knowledge of
customer.
k504............................ Clazinase customer Proprietary
specific. knowledge of
customer.
------------------------------------------------------------------------
0
66. In Sec. 866.5910, revise paragraph (b) to read as follows:
Sec. 866.5910 Quality control material for cystic fibrosis nucleic
acid assays.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 866.9. The
special control is FDA's guidance document entitled ``Class II Special
Controls Guidance Document: Quality Control Material for Cystic
Fibrosis Nucleic Acid Assays.'' See Sec. 866.1(e) for the availability
of this guidance document.
PART 868--ANESTHESIOLOGY DEVICES
0
67. The authority citation for part 868 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
68. In Sec. 868.1040, revise paragraph (b) to read as follows:
Sec. 868.1040 Powered algesimeter.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 868.9.
0
69. In Sec. 868.2385, revise paragraph (b) to read as follows:
Sec. 868.2385 Nitrogen dioxide analyzer.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a standalone nitrogen dioxide analyzer and not those that are
components of nitric oxide delivery systems intended to monitor
nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in Sec. 868.9. The special
control is FDA's ``Guidance Document for Premarket Notification
Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide
Analyzer, and Nitrogen Dioxide Analyzer.'' See Sec. 868.1(e) for the
availability of this guidance document.
0
70. In Sec. 868.2500, revise paragraph (b) to read as follows:
Sec. 868.2500 Cutaneous oxygen (PcO2) monitor.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 868.9. The
special control is FDA's ``Class II Special Controls Guidance Document:
Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance
for Industry and FDA.'' See Sec. 868.1(e) for the availability of this
guidance document.
0
71. In Sec. 868.2550, revise paragraph (b) to read as follows:
Sec. 868.2550 Pneumotachometer.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 868.9.
0
72. In Sec. 868.5180, revise paragraph (b) to read as follows:
Sec. 868.5180 Rocking bed.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 868.9.
0
73. In Sec. 868.6250, revise paragraph (b) to read as follows:
Sec. 868.6250 Portable air compressor.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 868.9.
PART 870--CARDIOVASCULAR DEVICES
0
74. The authority citation for part 870 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
75. In Sec. 870.1330, revise paragraph (b) to read as follows:
Sec. 870.1330 Catheter guide wire.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a torque device that is manually operated, non-patient
contacting, and intended to manipulate non-cerebral vascular guide
wires, is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to the limitations in Sec.
870.9.
0
76. In Sec. 870.1390, revise paragraph (b) to read as follows:
Sec. 870.1390 Trocar.
* * * * *
(b) Classification. Class II (special controls). Except for trocars
that are reprocessed for multiple use, the device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 870.9.
0
77. In Sec. 870.1650, revise paragraph (b) to read as follows:
Sec. 870.1650 Angiographic injector and syringe.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a non-patient contacting balloon inflation syringe intended only
to inflate/deflate balloon catheters and monitor pressure within the
balloon, is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 870.9.
0
78. In Sec. 870.1875, revise paragraph (b)(2) to read as follows:
Sec. 870.1875 Stethoscope.
* * * * *
(b) * * *
(2) Classification. Class II (special controls). The device, when
it is a lung sound monitor, is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 870.9.
[[Page 71812]]
0
79. In Sec. 870.2675, revise paragraph (b) to read as follows:
Sec. 870.2675 Oscillometer.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 870.9.
0
80. In Sec. 870.2770, revise paragraph (b) to read as follows:
Sec. 870.2770 Impedance plethysmograph.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a body composition analyzer which is not intended to diagnose or
treat any medical condition, is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 870.9.
0
81. In Sec. 870.4280, revise paragraph (b) to read as follows:
Sec. 870.4280 Cardiopulmonary prebypass filter.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 870.9.
0
82. In Sec. 870.4290, revise paragraph (b) to read as follows:
Sec. 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or
fitting.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 870.9.
0
83. In Sec. 870.4340, revise paragraph (b) to read as follows:
Sec. 870.4340 Cardiopulmonary bypass level sensing monitor and/or
control.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 870.9.
0
84. In Sec. 870.4400, revise paragraph (b) to read as follows:
Sec. 870.4400 Cardiopulmonary bypass blood reservoir.
* * * * *
(b) Classification. Class II (special controls), except that a
reservoir that contains a defoamer or filter is classified into the
same class as the defoamer or filter. The device, when it is a
cardiopulmonary bypass blood reservoir that does not contain defoamers
or blood filters, is exempt from the premarket notification procedures
in subpart E of part 807 of this chapter subject to the limitations in
Sec. 870.9.
0
85. In Sec. 870.4420, revise paragraph (b) to read as follows:
Sec. 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 870.9.
0
86. In Sec. 870.4430, revise paragraph (b) to read as follows:
Sec. 870.4430 Cardiopulmonary bypass intracardiac suction control.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 870.9.
PART 872--DENTAL DEVICES
0
87. The authority citation for part 872 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
88. In Sec. 872.1720, revise paragraph (b) to read as follows:
Sec. 872.1720 Pulp tester.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9.
0
89. In Sec. 872.3260, revise paragraph (b) to read as follows:
Sec. 872.3260 Cavity varnish.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is an external cleaning solution, is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 872.9.
0
90. In Sec. 872.3300, revise paragraph (b) to read as follows:
Sec. 872.3300 Hydrophilic resin coating for dentures.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9.
0
91. In Sec. 872.3540, revise paragraph (b)(2) introductory text to
read as follows:
Sec. 872.3540 OTC denture cushion or pad.
* * * * *
(b) * * *
(2) Class II (special controls) if the OTC denture cushion or pad
is made of a material other than wax-impregnated cotton cloth or if the
intended use of the device differs from that described in paragraph
(b)(1) of this section. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 872.9. The special controls for
this device are FDA's:
* * * * *
0
92. In Sec. 872.3560, revise paragraph (b) introductory text to read
as follows:
Sec. 872.3560 OTC denture reliner.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9. The
special controls for this device are FDA's:
* * * * *
0
93. In Sec. 872.3590, revise paragraph (b) to read as follows:
Sec. 872.3590 Preformed plastic denture tooth.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9.
0
94. In Sec. 872.3600, revise paragraph (b) introductory text to read
as follows:
Sec. 872.3600 Partially fabricated denture kit.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9. The
special controls for this device are FDA's:
* * * * *
0
95. In Sec. 872.3890, revise paragraph (b) to read as follows:
Sec. 872.3890 Endodontic stabilizing splint.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9.
0
96. In Sec. 872.5550, revise paragraph (b)(2) to read as follows:
Sec. 872.5550 Teething ring.
* * * * *
(b) * * *
[[Page 71813]]
(2) Class II (special controls) if the teething ring contains a
fluid, such as water. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 872.9.
0
97. In Sec. 872.6770, revise paragraph (b) to read as follows:
Sec. 872.6770 Cartridge syringe.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9.
PART 874--EAR, NOSE, AND THROAT DEVICES
0
98. The authority citation for part 874 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
99. In Sec. 874.1090, revise paragraph (b) to read as follows:
Sec. 874.1090 Auditory impedance tester.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a tympanometer or auditory impedance tester that complies with
FDA-recognized consensus standard ANSI S3.39, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 874.9.
0
100. In Sec. 874.1120, revise paragraph (b) to read as follows:
Sec. 874.1120 Electronic noise generator for audiometric testing.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 874.9.
0
101. In Sec. 874.1325, revise paragraph (b) to read as follows:
Sec. 874.1325 Electroglottograph.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 874.9.
0
102. In Sec. 874.3310, revise paragraph (b) to read as follows:
Sec. 874.3310 Hearing aid calibrator and analysis system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 874.9.
0
103. In Sec. 874.3320, revise paragraph (b) to read as follows:
Sec. 874.3320 Group hearing aid or group auditory trainer.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 874.9.
0
104. In Sec. 874.3330, revise paragraph (b) to read as follows:
Sec. 874.3330 Master hearing aid.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 874.9.
0
105. In Sec. 874.3430, revise paragraph (b) to read as follows:
Sec. 874.3430 Middle ear mold.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 874.9.
0
106. In Sec. 874.3730, revise paragraph (b) to read as follows:
Sec. 874.3730 Laryngeal prosthesis (Taub design).
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a voice amplification device, is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 874.9.
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
107. The authority citation for part 876 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
108. In Sec. 876.1500, revise paragraph (b)(1) to read as follows:
Sec. 876.1500 Endoscope and accessories.
* * * * *
(b) * * *
(1) Class II (special controls). The device, when it is an
endoscope disinfectant basin, which consists solely of a container that
holds disinfectant and endoscopes and accessories; an endoscopic
magnetic retriever intended for single use; sterile scissors for
cystoscope intended for single use; a disposable, non-powered
endoscopic grasping/cutting instrument intended for single use; a
diagnostic incandescent light source; a fiberoptic photographic light
source; a routine fiberoptic light source; an endoscopic sponge
carrier; a xenon arc endoscope light source; an endoscope transformer;
an LED light source; or a gastroenterology-urology endoscopic
guidewire, is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 876.9.
* * * * *
0
109. In Sec. 876.4020, revise paragraph (b) to read as follows:
Sec. 876.4020 Fiberoptic light ureteral catheter.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9.
0
110. In Sec. 876.4270, revise paragraph (b) to read as follows:
Sec. 876.4270 Colostomy rod.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9.
0
111. In Sec. 876.4400, revise paragraph (b) to read as follows:
Sec. 876.4400 Hemorrhoidal ligator.
* * * * *
(b) Classification. Class II (special controls). Except for a
hemostatic metal clip intended for use in the gastrointestinal tract,
the device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 876.9.
0
112. In Sec. 876.4500, revise paragraph (b) to read as follows:
Sec. 876.4500 Mechanical lithotriptor.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a biliary mechanical lithotripter, is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 876.9.
0
113. In Sec. 876.4770, revise paragraph (b) to read as follows:
Sec. 876.4770 Urethrotome.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9.
[[Page 71814]]
0
114. In Sec. 876.5010, revise paragraph (b) to read as follows:
Sec. 876.5010 Biliary catheter and accessories.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a bile collecting bag or a surgical biliary catheter that does
not include a balloon component, is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 876.9.
0
115. In Sec. 876.5025, revise paragraph (b) introductory text to read
as follows:
Sec. 876.5025 Vibrator for climax control of premature ejaculation.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9. The
special controls for this device are:
* * * * *
0
116. In Sec. 876.5160, revise the section heading and paragraph (b) to
read as follows:
Sec. 876.5160 Urological clamp.
* * * * *
(b) Classification. Class I (general controls). Except when
intended for internal use, the device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 876.9.
0
117. In Sec. 876.5365, revise paragraph (b) to read as follows:
Sec. 876.5365 Esophageal dilator.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9.
0
118. In Sec. 876.5520, revise paragraph (b)(1) to read as follows:
Sec. 876.5520 Urethral dilator.
* * * * *
(b) * * *
(1) Class II (special controls). Except when it is a mechanical
urethral dilator, the device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 876.9.
* * * * *
0
119. In Sec. 876.5630, revise paragraph (b) to read as follows:
Sec. 876.5630 Peritoneal dialysis system and accessories.
* * * * *
(b) Classification. Class II (special controls). The following
accessories are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 876.9: A catheter finger grip that is non-patient contacting and
intended for single use with a peritoneal catheter; a continuous
ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that
does not include weigh scales.
0
120. In Sec. 876.5665, revise paragraph (b) to read as follows:
Sec. 876.5665 Water purification system for hemodialysis.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a water purification subsystem disinfectant, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 876.9.
0
121. In Sec. 876.5895, revise paragraph (b) to read as follows:
Sec. 876.5895 Ostomy irrigator.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9.
0
122. In Sec. 876.5980, revise paragraph (b)(1) to read as follows:
Sec. 876.5980 Gastrointestinal tube and accessories.
* * * * *
(b) * * *
(1) Class II (special controls). The barium enema retention
catheter and tip with or without a bag that is a gastrointestinal tube
and accessory or a gastronomy tube holder accessory is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 876.9.
* * * * *
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
123. The authority citation for part 878 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
124. In Sec. 878.4370, revise paragraph (b) to read as follows:
Sec. 878.4370 Surgical drape and drape accessories.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is an ear, nose, and throat surgical drape, a latex sheet drape with
self-retaining finger cot, a disposable urological drape, a Kelly pad,
an ophthalmic patient drape, an ophthalmic microscope drape, an
internal drape retention ring (wound protector), or a surgical drape
that does not include an antimicrobial agent, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 878.9.
0
125. In Sec. 878.4495, revise paragraph (b) to read as follows:
Sec. 878.4495 Stainless steel suture.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a steel monofilament suture that is uncoated and does not
incorporate barbs, is exempt from the premarket notification procedures
in subpart E of part 807 of this chapter subject to the limitations in
Sec. 878.9. The special control for this device is FDA's ``Class II
Special Controls Guidance Document: Surgical Sutures; Guidance for
Industry and FDA.'' See Sec. 878.1(e) for the availability of this
guidance document.
0
126. In Sec. 878.4580, revise paragraph (b) to read as follows:
Sec. 878.4580 Surgical lamp.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is an operating room lamp, a surgical instrument light, a surgical
floor standing light, an endoscopic surgical light, a surgical light
connector, a ceiling mounted surgical light, a surgical light carrier,
surgical light accessories, a surgical lamp, a remote illuminator, or
an incandescent surgical lamp, is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 878.9.
0
127. In Sec. 878.5070, revise paragraph (b) to read as follows:
Sec. 878.5070 Air-handling apparatus for a surgical operating room.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is an air handling bench apparatus, an air handling room apparatus,
or an air handling enclosure apparatus, is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 878.9.
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
0
128. The authority citation for part 880 continues to read as follows:
[[Page 71815]]
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
129. In Sec. 880.5580, revise paragraph (b) introductory text to read
as follows:
Sec. 880.5580 Acupuncture needle.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is an acupuncture point locator or a single use acupuncture needle,
is exempt from the premarket notification procedures in subpart E of
part 807 of this chapter subject to the limitations in Sec. 880.9.
Acupuncture needles must comply with the following special controls:
* * * * *
0
130. In Sec. 880.5680, revise paragraph (b) to read as follows:
Sec. 880.5680 Pediatric position holder.
* * * * *
(b) Classification. Class I (general controls). Except when the
device is an infant positioner for prescription use in highly monitored
settings or an infant sleep position holder, it is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 880.9. The device is exempt
from the good manufacturing practice regulation in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
0
131. In Sec. 880.5780, revise paragraph (a)(2) to read as follows:
Sec. 880.5780 Medical support stocking.
(a) * * *
(2) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 880.9.
* * * * *
0
132. In Sec. 880.6250, revise paragraph (b) to read as follows:
Sec. 880.6250 Non-powdered patient examination glove.
* * * * *
(b) Classification. Class I (general controls). The device, when it
is a finger cot, is exempt from the premarket notification procedures
in subpart E of part 807 of this chapter subject to the limitations in
Sec. 880.9.
0
133. In Sec. 880.6375, revise paragraph (b) to read as follows:
Sec. 880.6375 Patient lubricant.
* * * * *
(b) Classification. Class I (general controls). Except when the
device is a vaginal patient lubricant or an oral lubricant, it is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 880.9.
0
134. In Sec. 880.6760, revise paragraph (b) to read as follows:
Sec. 880.6760 Protective restraint.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 880.9.
PART 882--NEUROLOGICAL DEVICES
0
135. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
136. In Sec. 882.1020, revise paragraph (b) to read as follows:
Sec. 882.1020 Rigidity analyzer.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9.
0
137. In Sec. 882.1030, revise paragraph (b) to read as follows:
Sec. 882.1030 Ataxiagraph.
* * * * *
(b) Classification. Class I (general controls). Except when the
device is intended to provide an interpretation or a clinical
implication of the measurement, it is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 882.9.
0
138. In Sec. 882.1470, revise paragraph (b) introductory text to read
as follows:
Sec. 882.1470 Computerized cognitive assessment aid.
* * * * *
(b) Classification. Class II (special controls). Except when the
computerized cognitive assessment aid is intended for diagnostic
assessment of specific diseases or conditions and relies on inputs from
visual cues, auditory cues, and/or functional use of the hand, the
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to the limitations in Sec.
882.9. The special control(s) for this device are:
* * * * *
0
139. In Sec. 882.1540, revise paragraph (b) to read as follows:
Sec. 882.1540 Galvanic skin response measurement device.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9.
0
140. In Sec. 882.1560, revise paragraph (b) to read as follows:
Sec. 882.1560 Skin potential measurement device.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9.
0
141. In Sec. 882.1855, revise paragraph (b) to read as follows:
Sec. 882.1855 Electroencephalogram (EEG) telemetry system.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9.
0
142. In Sec. 882.4060, revise paragraph (b) to read as follows:
Sec. 882.4060 Ventricular cannula.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9.
0
143. In Sec. 882.4545, revise paragraph (b) to read as follows:
Sec. 882.4545 Shunt system implantation instrument.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9.
0
144. In Sec. 882.5895, revise paragraph (b) introductory text to read
as follows:
Sec. 882.5895 Vibratory counter-stimulation device.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9. The
special controls for this device are:
* * * * *
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
0
145. The authority citation for part 884 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
[[Page 71816]]
0
146. In Sec. 884.1630, revise paragraph (b) to read as follows:
Sec. 884.1630 Colposcope.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a standard colposcope (or colpomicroscope) that uses only a white
light source, does not use filters other than a green filter, does not
include image analysis software, and is not smartphone-based, is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in Sec. 884.9.
0
147. In Sec. 884.2990, revise paragraph (b) to read as follows:
Sec. 884.2990 Breast lesion documentation system.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a breast examination recording sheet, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 884.9. The special control
is FDA's guidance entitled ``Class II Special Controls Guidance
Document: Breast Lesion Documentation System.'' See Sec. 884.1(e) for
the availability of this guidance document.
0
148. In Sec. 884.3200, revise paragraph (b) to read as follows:
Sec. 884.3200 Cervical drain.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 884.9.
0
149. In Sec. 884.4400, revise paragraph (b) to read as follows:
Sec. 884.4400 Obstetric forceps.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 884.9.
0
150. In Sec. 884.4530, revise paragraph (b)(1) to read as follows:
Sec. 884.4530 Obstetric-gynecologic specialized manual instrument.
* * * * *
(b) * * *
(1) Class II (special controls). The device, when it is an
umbilical clamp with or without a cutter, a uterine tenaculum which is
sterile and does not use suction and is intended for single use, a
nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum,
is exempt from the premarket notification procedures in subpart E of
part 807 of this chapter subject to the limitations in Sec. 884.9.
* * * * *
0
151. In Sec. 884.4900, revise paragraph (b) to read as follows:
Sec. 884.4900 Obstetric table and accessories.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 884.9.
0
152. In Sec. 884.5200, revise paragraph (b) introductory text to read
as follows:
Sec. 884.5200 Hemorrhoid prevention pressure wedge.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 884.9. The
special controls for this device are:
* * * * *
0
153. In Sec. 884.5390, revise paragraph (b) to read as follows:
Sec. 884.5390 Perineal heater.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 884.9.
0
154. In Sec. 884.5400, revise paragraph (b) to read as follows:
Sec. 884.5400 Menstrual cup.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 884.9.
0
155. In Sec. 884.5425, revise paragraph (b)(2) to read as follows:
Sec. 884.5425 Scented or scented deodorized menstrual pad.
* * * * *
(b) * * *
(2) Class II (special controls) for scented or scented deodorized
menstrual pads made of materials not described in paragraph (b)(1). The
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to the limitations in Sec.
884.9.
0
156. In Sec. 884.5435, revise paragraph (b) to read as follows:
Sec. 884.5435 Unscented menstrual pad.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 884.9 only when
the device is made of common cellulosic and synthetic material with an
established safety profile.
0
157. In Sec. 884.6120, revise paragraph (b) to read as follows:
Sec. 884.6120 Assisted reproduction accessories.
* * * * *
(b) Classification. Class II (special controls) (design
specifications, labeling requirements, and clinical testing). The
device, when it is a simple embryo incubator with only temperature,
gas, and humidity control; a syringe pump; a collection tube warmer; a
dish/plate/microscope stage warmer; or a controlled-rate
cryopreservation freezer, is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 884.9.
0
158. In Sec. 884.6130, revise paragraph (b) to read as follows:
Sec. 884.6130 Assisted reproduction microtools.
* * * * *
(b) Classification. Class II (special controls) (mouse embryo assay
information, endotoxin testing, sterilization validation, design
specifications, labeling requirements, and clinical testing). The
device, when the assisted reproduction microtools (pipettes) are
manufactured from glass, is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 884.9.
0
159. In Sec. 884.6150, revise paragraph (b) to read as follows:
Sec. 884.6150 Assisted reproduction micromanipulators and
microinjectors.
* * * * *
(b) Classification. Class II (special controls) (design
specifications, labeling requirements, and clinical testing). The
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to the limitations in Sec.
884.9.
0
160. In Sec. 884.6160, revise paragraph (b) to read as follows:
Sec. 884.6160 Assisted reproduction labware.
* * * * *
(b) Classification. Class II (special controls) (mouse embryo assay
information, endotoxin testing, sterilization validation, design
specifications, labeling requirements, and clinical testing). The
device, when
[[Page 71817]]
it is a dish or plate intended for general assisted reproduction
technology procedures, is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 884.9.
PART 886--OPHTHALMIC DEVICES
0
161. The authority citation for part 886 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
162. In Sec. 886.1120, revise paragraph (b) to read as follows:
Sec. 886.1120 Ophthalmic camera.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a photorefractor or a general-use ophthalmic camera, is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in Sec. 886.9.
0
163. In Sec. 886.1250, revise paragraph (b) to read as follows:
Sec. 886.1250 Euthyscope.
* * * * *
(b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 886.9.
(2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 886.9.
0
164. In Sec. 886.1570, revise paragraph (b) to read as follows:
Sec. 886.1570 Ophthalmoscope.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or
a hand-held ophthalmoscope replacement battery, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 886.9.
0
165. In Sec. 886.1780, revise paragraph (b)(1) to read as follows:
Sec. 886.1780 Retinoscope.
* * * * *
(b) * * *
(1) Class II (special controls) for the AC-powered device. The
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to the limitations in Sec.
886.9.
* * * * *
0
166. In Sec. 886.1850, revise paragraph (b) to read as follows:
Sec. 886.1850 AC-powered slitlamp biomicroscope.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is intended only for the visual examination of the anterior segment
of the eye, is classified as Group 1 per FDA-recognized consensus
standard ANSI Z80.36, does not provide any quantitative output, and is
not intended for screening or automated diagnostic indications, is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 886.9.
0
167. In Sec. 886.1945, revise paragraph (b) to read as follows:
Sec. 886.1945 Transilluminator.
* * * * *
(b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 886.9.
(2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 886.9.
0
168. In Sec. 886.3320, revise paragraph (b) to read as follows:
Sec. 886.3320 Eye sphere implant.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is an ocular peg which is supplied sterile only, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 886.9.
0
169. In Sec. 886.4070, revise paragraph (b) to read as follows:
Sec. 886.4070 Powered corneal burr.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 886.9.
0
170. In Sec. 886.4150, revise paragraph (b) to read as follows:
Sec. 886.4150 Vitreous aspiration and cutting instrument.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is phacofragmentation unit replacement tubing, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 886.9.
0
171. In Sec. 886.4250, revise paragraph (b) to read as follows:
Sec. 886.4250 Ophthalmic electrolysis unit.
* * * * *
(b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 886.9.
(2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 886.9.
0
172. In Sec. 886.4335, revise paragraph (b) to read as follows:
Sec. 886.4335 Operating headlamp.
* * * * *
(b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 886.9.
(2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 886.9.
0
173. In Sec. 886.4400, revise paragraph (b) to read as follows:
Sec. 886.4400 Electronic metal locator.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 886.9.
0
174. In Sec. 886.4440, revise paragraph (b) to read as follows:
Sec. 886.4440 AC-powered magnet.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 886.9.
0
175. In Sec. 886.4790, revise paragraph (b) to read as follows:
Sec. 886.4790 Ophthalmic sponge.
* * * * *
[[Page 71818]]
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 886.9.
PART 888--ORTHOPEDIC DEVICES
0
176. The authority citation for part 888 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
177. In Sec. 888.1240, revise paragraph (b) to read as follows:
Sec. 888.1240 AC-powered dynamometer.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 888.9.
0
178. In Sec. 888.4580, revise paragraph (b) to read as follows:
Sec. 888.4580 Sonic surgical instrument and accessories/attachments.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 888.9.
PART 890--PHYSICAL MEDICINE DEVICES
0
179. The authority citation for part 890 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
180. In Sec. 890.1450, revise paragraph (b) to read as follows:
Sec. 890.1450 Powered reflex hammer.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 890.9.
0
181. In Sec. 890.5100, revise paragraph (b) to read as follows:
Sec. 890.5100 Immersion hydrobath.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a hydromassage bath or a powered sitz bath, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 890.9.
0
182. In Sec. 890.5110, revise paragraph (b) to read as follows:
Sec. 890.5110 Paraffin bath.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 890.9.
0
183. In Sec. 890.5250, revise paragraph (b) to read as follows:
Sec. 890.5250 Moist steam cabinet.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 890.9.
0
184. In Sec. 890.5360, revise paragraph (b) to read as follows:
Sec. 890.5360 Measuring exercise equipment.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is a measuring exerciser, is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in Sec. 890.9.
0
185. In Sec. 890.5500, revise paragraph (b) to read as follows:
Sec. 890.5500 Infrared lamp.
* * * * *
(b) Classification. Class II (special controls). The device, when
it is an infrared therapeutic heating lamp, is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 890.9.
0
186. In Sec. 890.5575, revise paragraph (b) to read as follows:
Sec. 890.5575 Powered external limb overload warning device.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 890.9.
PART 892--RADIOLOGY DEVICES
0
187. The authority citation for part 892 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
188. In Sec. 892.1000, revise paragraph (b) to read as follows:
Sec. 892.1000 Magnetic resonance diagnostic device.
* * * * *
(b) Classification. Class II (special controls). A magnetic
resonance imaging disposable kit intended for use with a magnetic
resonance diagnostic device only is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 892.9.
0
189. In Sec. 892.1560, revise paragraph (b) to read as follows:
Sec. 892.1560 Ultrasonic pulsed echo imaging system.
* * * * *
(b) Classification. Class II (special controls). A biopsy needle
guide kit intended for use with an ultrasonic pulsed echo imaging
system only is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 892.9.
0
190. In Sec. 892.1610, revise paragraph (b) to read as follows:
Sec. 892.1610 Diagnostic x-ray beam-limiting device.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 892.9.
0
191. In Sec. 892.1650, revise paragraph (b) to read as follows:
Sec. 892.1650 Image-intensified fluoroscopic x-ray system.
* * * * *
(b) Classification. Class II (special controls). An anthrogram tray
or radiology dental tray intended for use with an image-intensified
fluoroscopic x-ray system only is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to the limitations in Sec. 892.9. In addition, when intended
as an accessory to the device described in paragraph (a) of this
section, the fluoroscopic compression device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 892.9.
0
192. In Sec. 892.1670, revise paragraph (b) to read as follows:
Sec. 892.1670 Spot-film device.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 892.9.
0
193. In Sec. 892.1680, revise paragraph (b) to read as follows:
Sec. 892.1680 Stationary x-ray system.
* * * * *
(b) Classification. Class II (special controls). A radiographic
contrast tray or radiology diagnostic kit intended for use with a
stationary x-ray system only is exempt from the premarket notification
procedures in subpart E of
[[Page 71819]]
part 807 of this chapter subject to the limitations in Sec. 892.9.
0
194. In Sec. 892.1730, revise paragraph (b) to read as follows:
Sec. 892.1730 Photofluorographic x-ray system.
* * * * *
(b) Classification. Class II (special controls). A discography kit
intended for use with a photofluorographic x-ray system only is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in Sec. 892.9.
0
195. In Sec. 892.1820, revise paragraph (b) to read as follows:
Sec. 892.1820 Pneumoencephalographic chair.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 892.9.
0
196. In Sec. 892.1850, revise paragraph (b) to read as follows:
Sec. 892.1850 Radiographic film cassette.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 892.9.
0
197. In Sec. 892.1860, revise paragraph (b) to read as follows:
Sec. 892.1860 Radiographic film/cassette changer.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 892.9.
0
198. In Sec. 892.1870, revise paragraph (b) to read as follows:
Sec. 892.1870 Radiographic film/cassette changer programmer.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 892.9.
0
199. In Sec. 892.1900, revise paragraph (b) to read as follows:
Sec. 892.1900 Automatic radiographic film processor.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 892.9.
0
200. In Sec. 892.2030, revise paragraph (b) to read as follows:
Sec. 892.2030 Medical image digitizer.
* * * * *
(b) Classification. Class II (special controls; voluntary
standards--Digital Imaging and Communications in Medicine (DICOM) Std.,
Joint Photographic Experts Group (JPEG) Std.). The device is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in Sec. 892.9.
0
201. In Sec. 892.2040, revise paragraph (b) to read as follows:
Sec. 892.2040 Medical image hardcopy device.
* * * * *
(b) Classification. Class II (special controls; voluntary
standards--Digital Imaging and Communications in Medicine (DICOM) Std.,
Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture
and Television Engineers (SMPTE) Test Pattern). The device is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in Sec. 892.9.
0
202. In Sec. 892.5730, revise paragraph (b) to read as follows:
Sec. 892.5730 Radionuclide brachytherapy source.
* * * * *
(b) Classification. Class II (special controls). A prostate seeding
kit intended for use with a radionuclide brachytherapy source only is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 892.9.
Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27394 Filed 12-27-19; 8:45 am]
BILLING CODE 4164-01-P