# K013837: Bio-Rad Platelia Toxo Igm TMB

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Sep 30, 2002 after 315 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K089398: Kallestad Diagnostics Platelia Toxo IgM. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Platelia Toxo IgM TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgM in human serum or plasma (EDTA, Heparin, Citrate). Note: Patient testing with the Platelia Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. The Platelia Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection. The performance of the Platelia Toxo IgM assay has not been established for neonate testing. The Platelia Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.

Source page: https://510kreport.com/device/K013837
Methodology: https://510kreport.com/methodology