# K963296: Incstar Toxoplasma Igg Alisa Assay (Cat.#7565)

- Pathway: 510(k) (Traditional)
- Applicant: Incstar Corp.
- Decided: Dec 16, 1996 after 117 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
Longest line of descent: 1 generation back to K915891 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915891: Toxo Igg Elisa Test (Modified), Gull Laboratories, Inc. (1992) Summary page 2.

## Indications for use
The INCSTAR Toxoplasma IgG ELISA kit contains instructions and materials for qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgG ELISA is of value in the determination of immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.

Source page: https://510kreport.com/device/K963296
Methodology: https://510kreport.com/methodology