# K955760: Toxoplasma Igg  in-Vitro Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Aug 2, 1996 after 226 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. The FDA summary names its predicate without a number.
- (no number) Abbott IMx Toxoplasma IgG assay: named in the summary without a submission number

## Indications for use
This in vitro diagnostic method in intended to quantitatively and qualitatively measure Toxoplasma IgG in human serum on the Technicon Immuno 1® System. Measurements of Toxoplasma IgG are designed to aid in the determination of serological status by detecting IgG class antibodies to Toxoplasma gondii in human sera. The Technicon Immuno 1 Toxoplasma IgG method is not intended for use in screening blood or plasma donors. The method is intended for in vitro diagnostic use only on the Technicon IMMUNO 1® system.

Source page: https://510kreport.com/device/K955760
Methodology: https://510kreport.com/methodology