# K133637: Alere Influenza a & B Test

- Pathway: 510(k) (Special)
- Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.
- Decided: Dec 18, 2013 after 41 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: 4 generations back to K001364 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103610: Clearview Exact II Influenza a & B Test, Alere Scarborough, Inc D/B/A Binax, Inc. (2011) Summary page 1.

## Indications for use
The Alerem Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. 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.

Source page: https://510kreport.com/device/K133637
Methodology: https://510kreport.com/methodology