# K013839: Bio-Rad Platelia Toxo Igg 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
- K089497: Bio-Rad Laboratories Platelia Toxo IgG. 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 IgG TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgG in human serum or plasma (EDTA, Heparin, Citrate). Note: The Platelia Toxo IgG TMB assay has not been cleared/approved by the FDA for blood/plasma donor screening.

Source page: https://510kreport.com/device/K013839
Methodology: https://510kreport.com/methodology