Cleared Traditional

K212769 - DYNEX SmartPLEX MMRV IgG Assay Kit (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212769 · Dynex Technologies, Inc. · Microbiology device
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Sep 2023
Decision
759d
Days
Class 2
Risk

K212769 is an FDA 510(k) clearance for the DYNEX SmartPLEX MMRV IgG Assay Kit. Classified as Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus (product code OPL), Class II - Special Controls.

Submitted by Dynex Technologies, Inc. (Chantilly, US). The FDA issued a Cleared decision on September 29, 2023 after a review of 759 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Dynex Technologies, Inc. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
657d slower than avg
Panel avg: 102d · This submission: 759d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OPL Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.