# K962936: Immulite Toxoplasma Quantitative Igg

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Apr 24, 1997 after 269 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. The FDA summary names its predicate without a number.
- (no number) bioMérieux Vitek VIDAS® Toxo IgG: named in the summary without a submission number
- (no number) Abbott Laboratories IMx® Toxo IgG: named in the summary without a submission number

## Indications for use
IMMULITE Toxoplasma Quantitative IgG is designed for the quantitative detection of IgG antibodies to Toxoplasma gondii in human serum and is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to Toxoplasma gondii.

Source page: https://510kreport.com/device/K962936
Methodology: https://510kreport.com/methodology