# K020694: QAB2A Igm Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cheshire Diagnostics, Ltd.
- Decided: Apr 19, 2002 after 46 days
- Product code: MVS (Kit, Typing, Hla-Dqb)
- 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 QAB,A IgM Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgM isotype autoantibody to B,-Glycoprotein-1 in human serum. The presence of B,-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/K020694
Methodology: https://510kreport.com/methodology