# K083746: Biosign Flu a+B

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Nov 10, 2010 after 693 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902609 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053146: Quickvue Influenza a + B Test, Quidel Corp. (2005) Summary page 1.

## Recalls of this device
- Mar 9, 2012 · Class II · Z-2306-2012: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
- Mar 9, 2012 · Class II · Z-2308-2012: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
- Mar 9, 2012 · Class II · Z-2307-2012: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

## Indications for use
The BioSign®~ Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasopharyngeal aspirate/wash specimens of patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Source page: https://510kreport.com/device/K083746
Methodology: https://510kreport.com/methodology