# K981651: AB Flu Oia

- Pathway: 510(k) (Traditional)
- Applicant: Biostar, Inc.
- Decided: Nov 25, 1998 after 198 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: 1 generation back to K902609 (1990). 1 ancestor in all.
45 later devices descend from it; 2 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)
- K902609: Directigen Flu a, Bd Becton Dickinson Vacutainer Systems Preanalytic (1990) Summary page 1.

## Most influential descendants
- K023556: Flu Oia a/B Test Kit (2003), 40 descendants of its own
- 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

## Indications for use
The BioStar@ FLU OIA assay is an Optical InmunoAssay (OIA) test for the qualitative, rapid detection of influenza A and B viral antigen (nucleoprotein) from nasal aspirate, nasopharyngeal swabs, throat swabs, or sputum specimens. This test is intended for in vitro use to aid in influenza A and B viral infections. The FLU OIA is not intended to detect influenza C. Negative test results should be confirmed by culture [isolation].

Source page: https://510kreport.com/device/K981651
Methodology: https://510kreport.com/methodology