Cleared Special

K222779 - Revogene (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222779 · Meridian Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
134d
Days
Class 2
Risk

K222779 is an FDA 510(k) clearance for the Revogene. Classified as Real Time Nucleic Acid Amplification System (product code OOI), Class II - Special Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 26, 2023 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2570 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Meridian Bioscience, Inc. devices

Submission Details

510(k) Number K222779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2022
Decision Date January 26, 2023
Days to Decision 134 days
Submission Type Special
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
32d slower than avg
Panel avg: 102d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OOI Real Time Nucleic Acid Amplification System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.2570
Definition The System Is A Clinical Multiplex Instrument Intended To Measure And Sort Multiple Signals Generated My Multiple Probes, Intercalating Dyes, Or Other Ligands In An Assay From A Clinical Sample. Signals May Be Generated By Fluorescence Or Other Phenomena And May Be Measured Using Filters On A Photodiode Or Other Detector. It May Integrate Sample And/or Reagent Handling, Amplification, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. The System Is Used With Specific Assays To Comprise An Assay Test System.
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.