OOI · Class II · 21 CFR 862.2570

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., bioMerieux, Inc. and Becton, Dickinson and Company.

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
1–14 of 14
Cleared Mar 20, 2025
Revogene
K243922
Meridian Bioscience, Inc.
Microbiology · 90d
Cleared Jan 26, 2023
Revogene
K222779
Meridian Bioscience, Inc.
Microbiology · 134d
Cleared Jul 11, 2022
Revogene
K220480
Meridian Bioscience, Inc.
Microbiology · 143d
Cleared May 20, 2014
BD VIPER LT SYSTEM
K140447
Becton, Dickinson and Company
Microbiology · 88d
Cleared Jul 06, 2010
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
K093383
bioMerieux, Inc.
Microbiology · 249d

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 →