# K133851: Alere PBP2A SA/Cons Culture Colony Test

- Pathway: 510(k) (Traditional)
- Applicant: Alere Scarborough, Inc.
- Decided: Sep 3, 2014 after 258 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 K011710 (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)
- K011710: Oxoid PBP2 1 Latex Agglutination Test, Oxoid, Ltd. (2002) Summary page 4.

## Indications for use
The Alere™ PBP2a SA Culture Colony Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus as an aid in identifying methicillin-resistant Staphylococcus aureus (MRSA).

Source page: https://510kreport.com/device/K133851
Methodology: https://510kreport.com/methodology