# K022992: Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001

- Pathway: 510(k) (Special)
- Applicant: Corgenix, Inc.
- Decided: Sep 25, 2002 after 16 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices 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.

## Most influential descendants
- K092181: Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls (2010), 3 descendants of its own
- K223093: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (2024), 0 descendants of its own
- K221359: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (2023), 0 descendants of its own
- K130528: Bioplex 2200 Apls Igm (2013), 0 descendants of its own
- K103834: Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets (2012), 0 descendants of its own

## Indications for use
An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM anti-cardiolipin antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).

Source page: https://510kreport.com/device/K022992
Methodology: https://510kreport.com/methodology