# K090301: Binaxnow PBP2A Test, Model 890-000

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Apr 14, 2010 after 432 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 K850291 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850291: Mueller Hinton Agar W/4% Nacl W/Antibiotics, Remel Co. (1985) Summary page 1.
- K011710: Oxoid PBP2 1 Latex Agglutination Test, Oxoid, Ltd. (2002)

## Most influential descendants
- K140619: Meca Xpressfish (2014), 0 descendants of its own

## Indications for use
The BinaxNOW® PBP2a Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) present in methicillin-resistant Staphylococcus aureus (MRSA). The test is performed directly on blood culture samples positive for S. aureus. The BinaxNOWO PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing or epidemiological typing.

Source page: https://510kreport.com/device/K090301
Methodology: https://510kreport.com/methodology