# K013077: Reaads Anti-Beta 2 Glycoprotein I Igm Test Kit

- Pathway: 510(k) (Special)
- Applicant: Corgenix, Inc.
- Decided: Sep 28, 2001 after 14 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.
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 REAADS Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and Qmi—quantimtion of IgM anti-B2GPI antibodies in buman 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.

Source page: https://510kreport.com/device/K013077
Methodology: https://510kreport.com/methodology