# K021610: QAB2A Igm Elisa Kit HRP

- Pathway: 510(k) (Traditional)
- Applicant: Cheshire Diagnostics, Ltd.
- Decided: Jul 12, 2002 after 57 days
- Product code: MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Cheshire Diagnostics Limited QAPzA IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semi-quantitative detection of IgM antibodies to P2-Giycoprotein-l in human serum. The presence of Pz-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other lupus like disorders.

Source page: https://510kreport.com/device/K021610
Methodology: https://510kreport.com/methodology