# K982433: Reaads Igm Anti-B2GP1 Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Corgenix, Inc.
- Decided: Dec 7, 1998 after 146 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 K973014 (1997). 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)
- K973014: Quanta Lite B2GPI Igm, Inova Diagnostics, Inc. (1997) Summary page 1.

## 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-B2GPJ antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS [gM anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K982433
Methodology: https://510kreport.com/methodology