# K973014: Quanta Lite B2GPI Igm

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Oct 20, 1997 after 68 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K982433: Reaads Igm Anti-B2GP1 Test Kit (1998), 0 descendants of its own

## Indications for use
A semiquantitative enzyme linked immunoassay for detecting IgM class autoantibody to B2 glycoprotein I (B2 GPI) for use as an aid in the diagnosis of certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like disorders.

Source page: https://510kreport.com/device/K973014
Methodology: https://510kreport.com/methodology