# K971441: Quanta Lite Toxoplasma Igg

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Dec 2, 1997 after 228 days
- Product code: LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- 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
The QUANTA Lite ™ Toxoplasma IgG ELISA System is designed for the semiquantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The test system is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and for in vitro diagnostic use. It can be used for prenatal screening for T. gondii IgG.

Source page: https://510kreport.com/device/K971441
Methodology: https://510kreport.com/methodology