# K072032: Igg Anti-Atherox Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Corgenix, Inc.
- Decided: Apr 4, 2008 after 255 days
- Product code: MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi))
- 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
Longest line of descent: 1 generation back to K022992 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022992: Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001, Corgenix, Inc. (2002) Summary page 1.

## Indications for use
An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with 032-glycoprotein I (0 2 GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

Source page: https://510kreport.com/device/K072032
Methodology: https://510kreport.com/methodology