# K020241: Qaca Igg/Igm Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cheshire Diagnostics, Ltd.
- Decided: Mar 13, 2002 after 49 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 is an Enzyme Linked Immunoassay for the in vitro semi-quantitative detection of IgG and IgM antibodies to cardiolipin in human serum.

Source page: https://510kreport.com/device/K020241
Methodology: https://510kreport.com/methodology