# K030701: Immulisa Anti-BETA2 Glycoprotein I (B2GP1) Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Sep 9, 2003 after 187 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
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgG antibodies to 132-GP 1, as an aid in assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) or lupus like disorders

Source page: https://510kreport.com/device/K030701
Methodology: https://510kreport.com/methodology