# K960712: Binax Strep a Test

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Mar 22, 1996 after 30 days
- Product code: GTZ (Antisera, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- 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 K901274 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934484: Quickvue in-Line One-Step Strep a Test, Quidel Corp. (1994) Summary page 1.
- K901274: Testpack Plus Strep a, Abbott Laboratories (1990) Summary page 1.
- K922345: Testpack Plus Strep a, Abbott Laboratories (1992) Summary page 1.

## Indications for use
The Binax Strep A Test is intended for in vitro diagnostic use in clinical and physician office laboratories to qualitatively detect the presence of Streptococcus pyogenes Group A antigen from throat swabs.

Source page: https://510kreport.com/device/K960712
Methodology: https://510kreport.com/methodology