# K091616: Bioplex 2200 MMRV Igg

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Mar 29, 2010 after 299 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: 1 generation back to K923122 (1992). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K961053: Seraquest Rubella Igg, Quest Intl., Inc. (1996)
- K923122: Vitek Immunodiagnostic Assay System, Biomerieux Vitek, Inc. (1992) Summary page 2.
- (no number) BioMerieux VIDAS Measles IgG (MSG): named in the summary without a submission number
- (no number) BioMerieux VIDAS Mumps IgG (MPG): named in the summary without a submission number

## Most influential descendants
- K212769: DYNEX SmartPLEX MMRV IgG Assay Kit (2023), 0 descendants of its own
- K111072: Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl (2011), 0 descendants of its own

## 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 neonates, pediatrics and immunocompromised patients, or for use at point of care facilities.

Source page: https://510kreport.com/device/K091616
Methodology: https://510kreport.com/methodology