# K062864: Mastalex -Mrsa, Model RST501

- Pathway: 510(k) (Traditional)
- Applicant: Mast Group, Ltd.
- Decided: Oct 18, 2006 after 23 days
- Product code: MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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 K011400 (2002). 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)
- K011400: Mrsa-Screen, Denka Seiken'S (2002) Summary page 2.

## Indications for use
A rapid slide latex test for the detection of penicillin binding protein 2' and the confirmation of Methicillin Resistant Staphylococcus aureus.

Source page: https://510kreport.com/device/K062864
Methodology: https://510kreport.com/methodology