# K031177: Diastat Anti-B2 Glycoprotein 1 Igm, Model FBGP 100M

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Jun 19, 2003 after 66 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 Diastat "Anti Beta 2 GLYCOPROTEIN I IgM test is a semiquantitative/qualitative enzyme-linked immunosorbent Assay (ELISA) for the detection the IgM class of autoantibodies to b2 GP1 in human serum, or sodium citrate, EDTA(K2). and lithium heparin anti-coagulated plasma. It is intended to aid in the assessment of thrombotic risk in patients with autoimmune disease associated with thrombotic disorders such as those with Primary Anti Phospholipid Syndrome (PAPS) or secondary to Systemic Lupus Erythematosus and is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.

Source page: https://510kreport.com/device/K031177
Methodology: https://510kreport.com/methodology