# K981263: Toxogen

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Aug 6, 1998 after 121 days
- Product code: GMM (Antigens, Iha, 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 K913467 (1993). 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)
- K913467: Toxogen, Biokit USA, Inc. (1993) Summary page 1.

## Indications for use
Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The test may be used with a single specimen to estimate the immunologic response of the individual or with paired acute and convalescent sera as an aid in the diagnosis of primary, acute or reactivated toxoplasmosis. This assay is not FDA cleared for use in blood or plasma donor screening.

Source page: https://510kreport.com/device/K981263
Methodology: https://510kreport.com/methodology