K212769 is an FDA 510(k) clearance for the DYNEX SmartPLEX MMRV IgG Assay Kit. This device is classified as a Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (Class II - Special Controls, product code OPL).
Submitted by Dynex Technologies, Inc. (Chantilly, US). The FDA issued a Cleared decision on September 29, 2023, 759 days after receiving the submission on August 31, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510. The Test Is A Multiplex Immunoassay Intended For The Qualitative Detection Of Specific Human Igg Antibodies To Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (vzv) In Human Serum And/ Or Plasma. The Results Of This Assay Are Intended To Be Used As An Aid In The Assessment Of A Patient¿s Serological Status To Measles Virus, Mumps Virus, Rubella And Vzv. The Test Is Not Intended For Use In Screening Blood Or Plasma Donors..
| 510(k) Number | K212769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2021 |
| Decision Date | September 29, 2023 |
| Days to Decision | 759 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OPL - Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |
| Definition | The Test Is A Multiplex Immunoassay Intended For The Qualitative Detection Of Specific Human Igg Antibodies To Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (vzv) In Human Serum And/ Or Plasma. The Results Of This Assay Are Intended To Be Used As An Aid In The Assessment Of A Patient¿s Serological Status To Measles Virus, Mumps Virus, Rubella And Vzv. The Test Is Not Intended For Use In Screening Blood Or Plasma Donors. |