U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. In Vitro Diagnostics
  5. Influenza Diagnostic Tests
  1. In Vitro Diagnostics

Influenza Diagnostic Tests

July 22, 2024

Laboratory developed tests (LDTs) for Highly Pathogenic Avian Influenza (HPAI) offered by clinical laboratories that are certified under CLIA and qualified to perform high-complexity testing currently fall under the FDA’s general enforcement discretion approach for LDTs. The FDA generally does not expect clinical laboratories that are certified under CLIA and qualified to perform high-complexity testing to request marketing authorization from the FDA for their LDTs for HPAI prior to them offering those LDTs.  And the FDA would not issue EUAs for such IVDs given that there is no relevant section 564 declaration.

Highly Pathogenic Avian Influenza (HPAI) is a disease that is highly contagious and often deadly in poultry, caused by highly pathogenic avian influenza A (H5) and A (H7) viruses; it is also known as bird or avian flu. HPAI viruses can be transmitted by wild birds to domestic poultry and other bird and animal species. Although bird flu viruses do not normally infect humans, sporadic human infections have occurred. It is important to note that “highly pathogenic” refers to severe impact in birds, not necessarily in humans. 

According to the U.S. Centers for Disease Control and Prevention (CDC), avian (bird) influenza (flu) A rarely infects people. CDC continues to monitor emergency department data and flu testing data for any unusual trends in flu-like illness, flu, or conjunctivitis. To date, surveillance systems do not show any unusual trends or activity.

In vitro diagnostic (IVD) products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions. IVDs include tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help diagnose, cure, treat, or prevent diseases. 

In response to requests from the public, the FDA is providing a list of in vitro diagnostic tests that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans. Most tests listed below for the detection of seasonal influenza may be capable of detecting influenza A/H5N1, which is a subtype of influenza A. However, only tests specifically designed for subtyping will be able to determine if the person has seasonal flu, or influenza A/H5. 

Influenza A/H5 Subtyping Tests

Influenza A/H5N1 Specific Detection Test 

Influenza A/H7N9 Specific Detection Test 

Influenza A/H1/H1pdm09/H3 Seasonal Subtyping Tests

Influenza A Tests (no subtyping)

Note:

Tests marked with (*) have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA) for home use.

Tests marked with (**) have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA) for use with home collected specimens.

Please be aware that one FDA 510(k) clearance, granted de novo request, or emergency use authorization (EUA) is linked for each device name. There may be additional FDA 510(k) clearances, granted de novo requests, or EUAs due to changes made over time while retaining the same device name.

Additional Resources 

Back to Top