# K021611: QAB2A Igg 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 IgG Efisa Kit HRP is an Enzyme Linked immunoassay for the in vitro semi-quantitative detection of IgG antibodies to P&lycoprotein-l in human serum. The presence of P2-GP1antibodies 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/K021611
Methodology: https://510kreport.com/methodology