# K991804: Bindazyme Anti-B2 Screen Eia Test Kit.

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: May 5, 2000 after 345 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
For the in-vitro qualitative screening IgG, A, M autoantibodies against B2-glycoprotein 1 (B2GPl) present in human serum. This kit may be wused in conjunction with anticardiolipin assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .

Source page: https://510kreport.com/device/K991804
Methodology: https://510kreport.com/methodology