# K992658: Osom Ultra Strep a Test, Model 147

- Pathway: 510(k) (Traditional)
- Applicant: Wyntek Diagnostics, Inc.
- Decided: Jan 18, 2000 after 162 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091489: Clearview Advanced Strep a , Model 737-430 (2009), 1 descendant of its own
- K122718: BD Veritor (TM) System for Rapid Detection of Group a Strep (2013), 0 descendants of its own

## Indications for use
The OSOM® Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A streptococcal antigen directly from throat swab specimens.

Source page: https://510kreport.com/device/K992658
Methodology: https://510kreport.com/methodology