# K062109: Binaxnow Influenza a & B Test

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Nov 9, 2006 after 108 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001364 (2000). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001364: BD Directigen Flu a+B, Bd Becton Dickinson Vacutainer Systems Preanalytic (2000) Summary page 1.

## Most influential descendants
- K092349: Clearview Exact II Influenza a & B Test (2010), 2 descendants of its own
- K103610: Clearview Exact II Influenza a & B Test (2011), 1 descendant of its own
- K092223: Modification to: Binaxnow Influenza  a & B Test (2009), 1 descendant of its own
- K071591: Ramp Influenza  a/B Assay (2008), 1 descendant of its own
- K133637: Alere Influenza a & B Test (2013), 0 descendants of its own

## Recalls of this device
- Mar 28, 2007 · Not classified · Z-0822-2007: Tip of the foam swab could detach from the shaft causing injury to the patient.
- Mar 28, 2007 · Not classified · Z-0823-2007: Tip of the foam swab could detach from the shaft causing injury to the patient.

## 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 results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.

Source page: https://510kreport.com/device/K062109
Methodology: https://510kreport.com/methodology