# K984317: The Aptus (Automated) Application of the Toxoplasma Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa)F

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jan 22, 1999 after 50 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Toxoplasma IgG ELISA test system provides a means for the manual and/or automated (Aptus), qualitative determination of IgG-class antibody to T. gondii in human serum. The test system s intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for in vitro diagnostic use. This productis not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

Source page: https://510kreport.com/device/K984317
Methodology: https://510kreport.com/methodology