# K961423: Osom Strep a Test

- Pathway: 510(k) (Traditional)
- Applicant: Wyntek Diagnostics, Inc.
- Decided: Oct 11, 1996 after 182 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
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. The FDA summary names its predicate without a number.
- (no number) Isolation of Group A Streptococcus colonies on sheep blood agar medium followed by a serological grouping of presumptive Group A Streptococcus: named in the summary without a submission number

## Indications for use
OSOM Strep A Test is an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.

Source page: https://510kreport.com/device/K961423
Methodology: https://510kreport.com/methodology