# K991633: Quickvue Influenza a/B Test

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Sep 24, 1999 after 135 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
No predicates in its family tree.
46 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) viral culture: named in the summary without a submission number

## Most influential descendants
- K031899: Quickvue Influenza a+B Test (2003), 34 descendants of its own
- 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

## Indications for use
The QuickVue Influenza A/B Test is intended for the qualitative detection of influenza Type A and Type B antigens directly from nasal swab, nasal wash and nasal aspirate specimens. The QuickVue Influenza A/B Test is intended for laboratory and professional use.

Source page: https://510kreport.com/device/K991633
Methodology: https://510kreport.com/methodology