# K982879: Shield Diastat Anti-B2 Glycoprotein 1 Igg (Elisa) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Shield Diagnostics, Ltd.
- Decided: Oct 15, 1998 after 62 days
- Product code: MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Oct 26, 2004 · Not classified · Z-0674-05: Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater

## Indications for use
The Diastat anti-f3, Glycoproteinl IgG Test is a semi-quantitative enzyme immunoassay for the detection, in human serum or plasma (citrate or EDTA anticoagulated), of the IgG class of autoantibodies specific for $,GP1 Antigen. The test is intended for use as an aid in the assessment of thrombotic risk in patients with autoimmune disease associated with thrombotic disorders such a primary anti-phospholipid syndrome, or secondary to Systemic Lupus Erythematosus. The test results are not definitive in isolation and represent one parameter in a multi-criterion diagnostic process. The option of a qualitative protocol is also available.

Source page: https://510kreport.com/device/K982879
Methodology: https://510kreport.com/methodology