# K041049: Binaxnow Influenza a & B Test

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Aug 10, 2004 after 110 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: 3 generations back to K902609 (1990). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021649: Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack, Binax, Inc. (2002) Summary page 1.
- K021646: Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack, Binax, Inc. (2002) Summary page 1.
- K023556: Flu Oia a/B Test Kit, Thermo Biostar, Inc. (2003) Summary page 1.

## Most influential descendants
- K053126: Binaxnow Influenza a & B Test (2005), 3 descendants of its own
- K063689: BD Directigen EZ Flu a+B Test (2007), 2 descendants of its own
- K101461: BD Directigen EX Flu a+B (2010), 0 descendants of its own
- K101529: BD Directigen EZ Flu a+B Assay (2010), 0 descendants of its own

## Indications for use
The BinaxNOW® Influenza A & B rest is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) 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 culture.

Source page: https://510kreport.com/device/K041049
Methodology: https://510kreport.com/methodology