Product Code: OOI FDA class 2 21 CFR 862.2570

Real Time Nucleic Acid Amplification System

Clinical Chemistry

The Real Time Nucleic Acid Amplification System (product code OOI) is a Class 1 clinical chemistry device regulated under 21 CFR 862.2570 in the Clinical Chemistry specialty (CH), exempt from premarket notification. It is a clinical multiplex instrument designed to measure and sort multiple signals from multiple probes or ligands in an assay, integrating sample handling, amplification, instrument control, data acquisition, and signal detection, and is used in conjunction with specific assays to form a complete test system. The device is not an implant or life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: OOI
Device Class: FDA class 2
Regulation Number: 862.2570
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243922	Revogene	Mar 20, 2025	Substantially Equivalent	Meridian Bioscience, Inc.
K222779	Revogene	Jan 26, 2023	Substantially Equivalent	Meridian Bioscience, Inc.
K220480	Revogene	Jul 11, 2022	Substantially Equivalent	Meridian Bioscience, Inc.
K170558	revogene	May 25, 2017	Substantially Equivalent	Genepoc, Inc.
K161495	ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)	Jun 30, 2016	Substantially Equivalent	Luminex Corporation
K160517	ARIES System	Apr 12, 2016	Substantially Equivalent	Luminex Corporation
K151917	ARIES System	Oct 06, 2015	Substantially Equivalent	Luminex Corporation
K151690	Alere i Instrument, Alere i Influenza A & B, Alere i Strep A	Jul 16, 2015	Substantially Equivalent	Alere Scarborough, Inc.
K140447	BD VIPER LT SYSTEM	May 20, 2014	Substantially Equivalent	Becton, Dickinson and Company
K123955	QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT	Mar 08, 2013	Substantially Equivalent	Life Technologies Corporation
K113319	ROTOR-GENE Q MDX	Feb 06, 2012	Substantially Equivalent	QIAGEN GmbH
K102314	3M INTEGRATED CYCLER (110V) & (220V)	Oct 29, 2010	Substantially Equivalent	Focus Diagnostics, Inc.
K093383	NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG	Jul 06, 2010	Substantially Equivalent	bioMerieux, Inc.
K092705	ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501	May 28, 2010	Substantially Equivalent	Abbott Molecular, Inc.