# K972030: Staphytect Plus/Dryspot Staphytect Plus

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid, Ltd.
- Decided: Sep 8, 1997 after 98 days
- Product code: JWX (Kit, Screening, Staphylococcus Aureus)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 7, 2008 · Not classified · Z-1008-2009: Control and test wells are reversed on some of the reaction cards.

## Indications for use
Staphyfect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.

Source page: https://510kreport.com/device/K972030
Methodology: https://510kreport.com/methodology