Cleared Traditional

K220480 - Revogene (FDA 510(k) Clearance)

K220480 · Meridian Bioscience, Inc. · Microbiology device
Jul 2022
Decision
143d
Days
Class 2
Risk

K220480 is an FDA 510(k) clearance for the Revogene. This device is classified as 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 July 11, 2022, 143 days after receiving the submission on February 18, 2022.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2570. 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..

Submission Details

510(k) Number K220480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2022
Decision Date July 11, 2022
Days to Decision 143 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.