# K170509: BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: May 19, 2017 after 87 days
- Product code: PUQ (Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933549 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092587: Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System, Bio-Rad Laboratories (2010) Summary page 6.
- K923166: Vidas Toxoplasma Gondii Igm Asssay, Biomerieux Vitek, Inc. (1993) Summary page 6.

## Indications for use
BioPlex 2200 ToRC IgM Kit The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin). The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child bearing age. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors. Performance characteristics for the ToRC IgM assay have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities. BioPlex 2200 ToRC IgM Calibrator Set The BioPlex 2200 ToRC IgM Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgM Reagent Pack. BioPlex 2200 ToRC IgM Control Set The BioPlex 2200 ToRC IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 ToRC IgM Reagent Pack in the clinical laboratory.

Source page: https://510kreport.com/device/K170509
Methodology: https://510kreport.com/methodology