# K970551: Quanta Lite B2GPI Igg

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 24, 1997 after 132 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 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
- K223093: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (2024), 0 descendants of its own
- K152875: QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls (2015), 0 descendants of its own
- K141274: Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI DOMAIN1; Controls. (2015), 0 descendants of its own
- K982391: Reaads Igg Anti-B2GPI Test Kit (1998), 0 descendants of its own

## Indications for use
A semiquantitative enzyme linked immunoassay for detecting IgG class autoantibody to β2 glycoprotein I (β2 GPI), for use as an aid in the diagnosis of certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus or other lupus like thrombotic diseases.

Source page: https://510kreport.com/device/K970551
Methodology: https://510kreport.com/methodology