# K091489: Clearview Advanced Strep a , Model 737-430

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Sep 4, 2009 after 107 days
- Product code: GTY (Antigens, 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 K992658 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992658: Osom Ultra Strep a Test, Model 147, Wyntek Diagnostics, Inc. (2000) Summary page 1.

## Most influential descendants
- K122718: BD Veritor (TM) System for Rapid Detection of Group a Strep (2013), 0 descendants of its own

## Indications for use
The Clearview Advanced M Strep AT test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens as an aid in the diagnosis of Group A Streptococcal infection.

Source page: https://510kreport.com/device/K091489
Methodology: https://510kreport.com/methodology