# K023556: Flu Oia a/B Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Biostar, Inc.
- Decided: Mar 27, 2003 after 155 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902609 (1990). 2 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981651: AB Flu Oia, Biostar, Inc. (1998) Summary page 1.

## 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

## Recalls of this device
- Jul 2, 2008 · Not classified · Z-0212-2009: Diagnostic kits for flu were distributed with incorrect components.

## Indications for use
The Thermo BioStarr" FLU OIA' A/B assay is an Optical ImmunoAssay test for the qualitative, rapid detection of influenza A and B viral antigens (nucleoproteins) extracted from nasal aspirate, nasopharyngeal swab, throat swab, and sputum specimens. This test is intended for in vitro diagnostic use to aid in the differential diagnosis of influenza A and B viral infections. The FLU OIA A/B test is not intended for detection of influenza C. Negative test results should be confirmed by cell culture.

Source page: https://510kreport.com/device/K023556
Methodology: https://510kreport.com/methodology