# K021192: Qaca Igg/Igm Elisa Kit HRP

- Pathway: 510(k) (Traditional)
- Applicant: Cheshire Diagnostics, Ltd.
- Decided: May 16, 2002 after 31 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- 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 QACA IgG/IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semi-quantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum. The presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.

Source page: https://510kreport.com/device/K021192
Methodology: https://510kreport.com/methodology