# K121905: Alere PBP2A Test

- Pathway: 510(k) (Special)
- Applicant: Alere Scarborough, Inc.
- Decided: Jul 26, 2012 after 27 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: 2 generations back to K850291 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091766: Clearview Exact PBP2A Test, Model 891-000, Binax, Inc. (2010) Summary page 1.

## Indications for use
The Alere M PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Alere M PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

Source page: https://510kreport.com/device/K121905
Methodology: https://510kreport.com/methodology