# K960092: Seraquest Toxoplasma Igg

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Jun 17, 1996 after 158 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) Toxoplasma IgG Clin-ELISA™ kit, INCSTAR Corporation: named in the summary without a submission number

## Indications for use
For the detection of human IgG antibodies to toxoplasma virus in human serum by enzyme immunoasay, to aid in the serological assessment of single samples and the diagnosis of primary infection in paired sera through the detection of seroconversion of Toxoplasma specific IgG gntibody. These reagents have not received FDA clearance for use in testing blood or plasma donors.

Source page: https://510kreport.com/device/K960092
Methodology: https://510kreport.com/methodology