# K971989: Toxoplasma Igm Assay for the Bayer IMMUNO1 System (in Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Oct 22, 1997 after 146 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 IgM assay: named in the summary without a submission number

## Indications for use
This in vitro diagnostic method is intended to qualitatively measure IgM antibodies to Toxoplasma gondii in human serum using the Bayer Immuno 1™ system. Measurements of anti-Toxoplasma IgM antibodies are presumptive for the diagnosis of recent Toxoplasma infection. Anti-Toxoplasma gondii IgM antibody measurements must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This method has not been cleared or approved by the FDA for blood or plasma donor screening. The use of the Bayer Immuno 1 Toxoplasma IgM method has not been validated for testing of cord blood or neonatal serum. This method is intended for in vitro diagnostic use only on the Bayer Immuno 1 system.

Source page: https://510kreport.com/device/K971989
Methodology: https://510kreport.com/methodology