# K992243: Virgo Beta 2 Glycoprotein Igm Antibody Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Aug 30, 1999 after 60 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
Longest line of descent: 1 generation back to K932373 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932373: Hemagen Cardiolipin Antibody Kit (Eia METHOD0, Hemagen Diagnostics, Inc. (1993) Summary page 1.

## Indications for use
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of circulating IgM antibadies to B, Glycoprotein in human serum. The presence of these antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Primary and Secondary Antiphospholipid Syndrome.

Source page: https://510kreport.com/device/K992243
Methodology: https://510kreport.com/methodology