# K083278: Avc a/H5N1 Flu Test

- Pathway: 510(k) (Traditional)
- Applicant: Arbor Vita Corportation
- Decided: Apr 8, 2009 after 152 days
- Product code: OMS (Novel Influenza A Virus, A/H5 Ns1 Protein)
- Device class: 2
- Regulation: 21 CFR 866.3332
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902609 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel, Centers for Disease Control and Prevention (2008) Summary page 2.
- K053146: Quickvue Influenza a + B Test, Quidel Corp. (2005) Summary page 2.

## Indications for use
The AVantage TM A/H5N1 Flu Test is intended for the in vitro qualitative detection of influenza A/H5N1 virus directly from symptomatic patient nasal or throat swab specimens or in viral cultures for the presumptive laboratory identification of influenza A/H5N1 virus. Results from testing with the AVantage TM A/H5N1 Flu Test should be used in conjunction with other laboratory testing and clinical and epidemiological risk factors for the presumptive identification of patients infected with Influenza H5N1 virus. AVantage TM A/H5N1 Flu Test is intended as a Prescription Use device. Testing should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 either directly from patient specimens or from viral cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Source page: https://510kreport.com/device/K083278
Methodology: https://510kreport.com/methodology