# K962146: Excel Onestep Group a Strep Antigen Module Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Excel Scientific, Inc.
- Decided: Oct 7, 1996 after 126 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 no predicate by number.

## Indications for use
Excel OneStep Group A Strep Antigen Module Test is Excel Scientific, Inc.'s name for the professional use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of group A strep antigen from throat swabs.

Source page: https://510kreport.com/device/K962146
Methodology: https://510kreport.com/methodology