# K972790: The Theratest EL-B2GP1 (Igm, Igg, Iga) and EL-B2GP1SCR

- Pathway: 510(k) (Traditional)
- Applicant: Theratest Laboratories, Inc.
- Decided: Dec 5, 1997 after 130 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 TheraTest EL-B2GP1 (IgM, IgG, IgA) is an in vitro diagnostic tests for the measurement of IgM, IgG and IgA autoantibodies in human serum directed against the serum glycoprotein Beta 2 Glycoprotein 1 (B2GP1) . This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

Source page: https://510kreport.com/device/K972790
Methodology: https://510kreport.com/methodology