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..
FDA 510(k) Cleared Real Time Nucleic Acid Amplification System Devices (Product Code OOI)
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 declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
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 →