510(k) K212769
K212769 is an FDA 510(k) premarket notification submitted by Dynex Technologies, Inc. for the device "DYNEX SmartPLEX MMRV IgG Assay Kit". The FDA issued a decision of Substantially Equivalent on September 29, 2023. The device falls under product code OPL (Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus), a Class II device regulated under 21 CFR 866.3510.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2023
- Date Received
- August 31, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
- Device Class
- Class II
- Regulation Number
- 866.3510
- Review Panel
- MI
- Submission Type
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.