# K092223: Modification to: Binaxnow Influenza  a & B Test

- Pathway: 510(k) (Special)
- Applicant: Binax, Inc.
- Decided: Aug 12, 2009 after 20 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001364 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062109: Binaxnow Influenza a & B Test, Binax, Inc. (2006) Summary page 1.

## Most influential descendants
- K133411: Alere Binaxnow Influenza a & B Card (2013), 0 descendants of its own

## Indications for use
The BinaxNOW® Influenza A & B Test 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 should be confirmed by cell culture.

Source page: https://510kreport.com/device/K092223
Methodology: https://510kreport.com/methodology