# K971672: Seraquest Toxoplasma Igm

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Oct 21, 1997 after 167 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 IgM Clin-ELISA™ kit, INCSTAR Corporation: named in the summary without a submission number

## Indications for use
1. For the qualitative, semi-quantitative, and quantitative detection of IgM antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. 2. A positive result is presumptive for the detection of anti- Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection. 3. Patient testing with the SeraQuest Toxoplasma IgM assay must be accompanied by an anti-toxoplasma: 1gG antibodyassay.” 4, Useful for the above indications, with specimens obtained from women of childbearing age and during pregnancy. 5. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Source page: https://510kreport.com/device/K971672
Methodology: https://510kreport.com/methodology