# K091766: Clearview Exact PBP2A Test, Model 891-000

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Feb 24, 2010 after 252 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.
4 later devices descend from it; 2 cite it directly.
0 of 7 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) Summary page 1.

## Most influential descendants
- K162385: Rapidec Carba NP (2017), 2 descendants of its own
- K191889: NG-Test CARBA 5 (2019), 1 descendant of its own
- K243499: NG-Test® CTX-M MULTI (2025), 0 descendants of its own
- K121905: Alere PBP2A Test (2012), 0 descendants of its own

## Indications for use
The Clearview® Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (FBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRA) The Clearview® Exact PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

Source page: https://510kreport.com/device/K091766
Methodology: https://510kreport.com/methodology