# K963289: Incstar Toxoplasma Igm Capture Elisa Assay

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: May 1, 1997 after 253 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) BioWhittaker TOXOCAP-M ELISA test: named in the summary without a submission number

## Most influential descendants
- K052499: Diasorin Liaison Toxo Igg and Liaison Toxo Igm Assays (2006), 0 descendants of its own

## Indications for use
The INCSTAR Toxoplasma IgM Capture ELISA kit contains instructions and materials for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active Toxoplasma gondii infection. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.

Source page: https://510kreport.com/device/K963289
Methodology: https://510kreport.com/methodology