# K111072: Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories
- Decided: Aug 23, 2011 after 127 days
- Product code: OPL (Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus)
- 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 K923122 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091616: Bioplex 2200 MMRV Igg, Bio-Rad Laboratories (2010) Summary page 1.

## Indications for use
The BioPlex® 2200 MMRV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella and Varicella-zoster virus (VZV) in human serum and EDTA or heparinized plasma. The BioPlex 2200 MMRV 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 Measles, Mumps, Rubella, and VZV. This kit is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in neonatal, pediatrics and immunocompromised patients, or for use at point of care facilities. The BioPlex® 2200 MMRV IgG Calibrator Set is intended for the calibration of the BioPlex® 2200 MMRV IgG Reagent Pack. The BioPlex® 2200 MMRV IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 MMRV IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 MMRV IgG Control Set has not been established with any other Measles, Mumps, Rubella or VZV IgG assays.

Source page: https://510kreport.com/device/K111072
Methodology: https://510kreport.com/methodology