# K012449: Diamedix IS-Anti-Cardiolipin Igg/Igm Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Oct 26, 2001 after 86 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. The FDA summary names its predicate without a number.
- (no number) Orgentec Anti-cardiolipin ELISA Assay: named in the summary without a submission number

## Indications for use
The Diamedix Is anti-Cardiolipin IgG/IgM Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

Source page: https://510kreport.com/device/K012449
Methodology: https://510kreport.com/methodology