# K022944: Autostat II Anti-B-2 Glycoprotein-I Igm Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Hycor Biomedical, Inc.
- Decided: Dec 18, 2002 after 104 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
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to 13-2 Glycoprotein-I (13-2 GPI) antibodies in human serum, Uses: The results of the anti- p -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-P-2 GPI antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. This device can be used with the HYCOR HY-TEC automated EIA instrument. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K022944
Methodology: https://510kreport.com/methodology