# K962060: Strep a Oia Max

- Pathway: 510(k) (Traditional)
- Applicant: Biostar, Inc.
- Decided: Jul 23, 1997 after 421 days
- Product code: GTZ (Antisera, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Apr 6, 2009 · Not classified · Z-1506-2009: Potential for false positive Strep A results.

## Indications for use
The BioStar® STREP A OIA® MAX assay is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for in vitro diagnostic use to rapidly identify Group A Streptococci in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis as an aid in the diagnosis of streptococcal infection.

Source page: https://510kreport.com/device/K962060
Methodology: https://510kreport.com/methodology