# K972182: Abbott Strep a Controls

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diagnostics
- Decided: Aug 13, 1997 after 76 days
- Product code: MJZ (Kit, Direct Antigen, Positive Control)
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K922490 (1992). 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)
- K922490: Abbott Strep a Controls, Abbott Laboratories (1992) Summary page 1.

## Indications for use
Abbott STREP A Controls are qualitative control materials intended for use in test systems to monitor substantial reagent failure and procedural errors. Specifically, Abbott STREP A Controls are intended for use as external controls in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen.

Source page: https://510kreport.com/device/K972182
Methodology: https://510kreport.com/methodology