# K984170: The Aptus (Automated) Application of the Toxoplasma Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jan 19, 1999 after 60 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 IgM ELISA test system provides a means for the manual and/or automated (Aptus), presumptive, qualitative determination of IgM-class antibody to T. gondii in human serum and for the presumptive diagnosos of acute, recent, or reactive infection. To adequately assess the patient's serological status, testing must be performed in conjunction with an anti-Toxoplasma gondii igG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. The assay’s performance has not been established for screening of prenatal women or newboms.

Source page: https://510kreport.com/device/K984170
Methodology: https://510kreport.com/methodology