# K212769: DYNEX SmartPLEX MMRV IgG Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dynex Technologies, Inc.
- Decided: Sep 29, 2023 after 759 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 5.

## Indications for use
The DYNEX SmartPLEX MMRV IgG Assay Kit is a multiplex immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended for use with the DYNEX Multiplier Analyzer. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended to be used as an aid in the determination of serological status to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum from adults and pediatrics age above 1 year. This kit is not intended for screening blood or plasma donors. The performance of this device has not been established for use in neonates, pediatric patients below 1 year of age, and immunocompromised patients, or for use at point of care facilities.

Source page: https://510kreport.com/device/K212769
Methodology: https://510kreport.com/methodology