Cleared Traditional

Revogene

K243922 · Meridian Bioscience, Inc. · Microbiology

Mar 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K243922 is an FDA 510(k) clearance for the Revogene, a Real Time Nucleic Acid Amplification System (Class II — Special Controls, product code OOI), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 20, 2025, 90 days after receiving the submission on December 20, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K243922 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2024
Decision Date	March 20, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OOI — Real Time Nucleic Acid Amplification System
Device Class	Class II — 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.