# K092698: Quickvue Influenza a+B Test

- Pathway: 510(k) (Special)
- Applicant: Quidel Corp.
- Decided: Sep 15, 2009 after 13 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: 5 generations back to K902609 (1990). 7 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031899: Quickvue Influenza a+B Test, Quidel Corp. (2003) Summary page 1.
- K053146: Quickvue Influenza a + B Test, Quidel Corp. (2005) Summary page 1.

## Most influential descendants
- K112277: BD Veritor (TM) System for Rapid Detection of Flu a+B (2011), 20 descendants of its own
- K132259: BD Veritor System for the Rapid Detection of Flu a+B (2013), 19 descendants of its own
- K132692: BD Veritor System for the Rapid Detection of Flu a+B (2013), 17 descendants of its own
- K151291: BD Veritor (TM) System for the Rapid Detection of Flu A+B (2015), 11 descendants of its own
- K152870: BD Veritor System  for the Rapid Detection of Flu A + B CLIA waived kit (2015), 10 descendants of its own

## Indications for use
The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative results should be confirmed by cell culture; they 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/K092698
Methodology: https://510kreport.com/methodology