# K011710: Oxoid PBP2 1 Latex Agglutination Test

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid, Ltd.
- Decided: Apr 2, 2002 after 302 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
No predicates in its family tree.
25 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033415: Idi-Mrsa (2004), 14 descendants of its own
- K070462: Xpert Mrsa (2007), 10 descendants of its own
- K093346: BD Geneohm Mrsa Acp Assay (2009), 7 descendants of its own
- K120138: BD Max Mrsa Assay, BD Max Instrument (2012), 4 descendants of its own
- K091766: Clearview Exact PBP2A Test, Model 891-000 (2010), 4 descendants of its own

## Indications for use
This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.

Source page: https://510kreport.com/device/K011710
Methodology: https://510kreport.com/methodology