# K080008: Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Feb 23, 2009 after 418 days
- Product code: OMI (Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv)
- 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: 1 generation back to K902925 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993319: Vidas Toxo Igg II (TXG) Assay Model 30 210, bioMerieux, Inc. (2000) Summary page 1.
- K902925: Vitek Immunodiagnostic Assay System (Vidas) (RBG), Vitek Systems, Inc. (1990) Summary page 1.
- K920661: Vidas CMV Igg Assay, Vitek Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- K120572: Bioplex 2200 Torc Igg (2012), 0 descendants of its own

## Indications for use
The BioPlex 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondi) and Rubella, and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma. The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors. Performance characteristics for T. gondii and Rubella have not been evaluated in immunocompromised or immunosuppressed individuals. Performance characteristics for CMV 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 a point of care. The BioPlex 2200 ToRC IgG Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgG Reagent Pack. The BioPlex 2200 ToRC IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex ToRG IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 ToRC IgG Control Set has not been established with any other Toxoplasma gondii, Rubella or Cytomegalovirus (CMV) IgG antibody assays.

Source page: https://510kreport.com/device/K080008
Methodology: https://510kreport.com/methodology