# K031899: Quickvue Influenza a+B Test

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Sep 11, 2003 after 99 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). 5 ancestors in all.
34 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991633: Quickvue Influenza a/B Test, Quidel Corp. (1999) Summary page 1.
- K001364: BD Directigen Flu a+B, Bd Becton Dickinson Vacutainer Systems Preanalytic (2000) Summary page 1.
- K023556: Flu Oia a/B Test Kit, Thermo Biostar, Inc. (2003) Summary page 1.

## Most influential descendants
- K053146: Quickvue Influenza a + B Test (2005), 27 descendants of its own
- K092698: Quickvue Influenza a+B Test (2009), 24 descendants of its own
- 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

## 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, nasal wash and nasal aspirate 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.

Source page: https://510kreport.com/device/K031899
Methodology: https://510kreport.com/methodology