# K090847: Platelia Toxo Igm Kit Model 26211

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories
- Decided: Jul 1, 2009 after 93 days
- Product code: LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- May 30, 2025 · Class II · Z-2515-2025: Due to a risk of false positive results that could lead to unnecessary medical treatment.

## Indications for use
The PlateliaTM Toxo IgM kit is an in-vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasmagondii in human serum or plasma (EDTA, Heparin, Citrate) Note: * Patient testing with the PlateliaTM Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. The PlateliaTM 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 PlateliaTM Toxo IgM assay has not been established for neonate testing. The PlateliaTm Toxo igM assay has not been cleared/approved by the FDA for blood/plasma donor screening.

Source page: https://510kreport.com/device/K090847
Methodology: https://510kreport.com/methodology