# K133411: Alere Binaxnow Influenza a & B Card

- Pathway: 510(k) (Special)
- Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.
- Decided: Dec 5, 2013 after 28 days
- Product code: GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C)
- Device class: 1
- Regulation: 21 CFR 866.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001364 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092223: Modification to: Binaxnow Influenza  a & B Test, Binax, Inc. (2009) Summary page 1.

## Indications for use
The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Caution: Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples.

Source page: https://510kreport.com/device/K133411
Methodology: https://510kreport.com/methodology