# K031208: Reaads Igm Anti-B2GPI Test Kit, Model 038-001

- Pathway: 510(k) (Special)
- Applicant: Corgenix, Inc.
- Decided: Jul 7, 2003 after 81 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K091556: Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, 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

## Indications for use
The REAADS IgM Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgM anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories. The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgA anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories. The REAADS IgG Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgG Anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories. The REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories. The REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K031208
Methodology: https://510kreport.com/methodology