# K962296: Streptolex-Stat

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: Dec 16, 1996 after 187 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 K854929 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854929: Oxoid Streptococal Grouping Kit, Oxoid U.S.A., Inc. (1986) Summary page 2.
- (no number) Streptex and Streptex - Acid Extraction Kit: named in the summary without a submission number
- (no number) PathoDx® Strep Grouping: named in the summary without a submission number

## Indications for use
STREPTOLEX-STAT™ is substantially equivalent to several commercially available products utilizing similar methodology for the identification of streptococcal groups A, B, C,F and G.

Source page: https://510kreport.com/device/K962296
Methodology: https://510kreport.com/methodology