FDA Product Code OOI: Real Time Nucleic Acid Amplification System
Real-time nucleic acid amplification systems provide rapid, instrument-based molecular testing at the point of care. FDA product code OOI covers clinical multiplex real-time PCR instrument systems.
These integrated platforms perform nucleic acid extraction and amplification in a closed cartridge system, delivering results for multiple targets within 1-2 hours directly in clinical laboratories, emergency departments, and point-of-care settings.
OOI devices are Class II medical devices, regulated under 21 CFR 862.2570 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Meridian Bioscience, Inc., Luminex Corporation and Genepoc, Inc..
14
Total
14
Cleared
106d
Avg days
2010
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
90d
recently vs 107d historically
FDA 510(k) Cleared Real Time Nucleic Acid Amplification System Devices (Product Code OOI)
14 devices
Cleared
Mar 20, 2025
Revogene
Meridian Bioscience, Inc.
Microbiology
90d
Cleared
Jan 26, 2023
Revogene
Meridian Bioscience, Inc.
Microbiology
134d
Cleared
Jul 11, 2022
Revogene
Meridian Bioscience, Inc.
Microbiology
143d
Cleared
May 25, 2017
revogene
Genepoc, Inc.
Microbiology
90d
Cleared
Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
Luminex Corporation
Microbiology
29d
Cleared
Apr 12, 2016
ARIES System
Luminex Corporation
Microbiology
48d
Cleared
Oct 06, 2015
ARIES System
Luminex Corporation
Chemistry
85d
Cleared
Jul 16, 2015
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
Alere Scarborough, Inc.
Microbiology
23d
Cleared
May 20, 2014
BD VIPER LT SYSTEM
Becton, Dickinson and Company
Microbiology
88d
Cleared
Mar 08, 2013
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
Life Technologies Corporation
Microbiology
77d
Cleared
Feb 06, 2012
ROTOR-GENE Q MDX
QIAGEN GmbH
Microbiology
88d
Cleared
Oct 29, 2010
3M INTEGRATED CYCLER (110V) & (220V)
Focus Diagnostics, Inc.
Microbiology
74d
Cleared
Jul 06, 2010
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
bioMerieux, Inc.
Microbiology
249d
Cleared
May 28, 2010
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
Abbott Molecular, Inc.
Microbiology
267d
About Product Code OOI - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code OOI since 2010, with 14 receiving FDA clearance (average review time: 106 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - OOI Product Code
Recent submissions under OOI have taken an average of 90 days to reach a decision - down from 107 days historically, suggesting improved FDA processing for this classification.
OOI devices are reviewed by the Microbiology panel. Browse all Microbiology devices →