OOI · Real Time Nucleic Acid Amplification System
Clinical Chemistry · 21 CFR 862.2570 · Class 2
Overview
| Product Code | OOI |
|---|---|
| Device Name | Real Time Nucleic Acid Amplification System |
| Regulation | 21 CFR 862.2570 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243922 | Revogene | Meridian Bioscience, Inc. | Mar 20, 2025 | SESE |
| K222779 | Revogene | Meridian Bioscience, Inc. | Jan 26, 2023 | SESE |
| K220480 | Revogene | Meridian Bioscience, Inc. | Jul 11, 2022 | SESE |
| K170558 | revogene | Genepoc, Inc. | May 25, 2017 | SESE |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) | Luminex Corporation | Jun 30, 2016 | SESE |
| K160517 | ARIES System | Luminex Corporation | Apr 12, 2016 | SESE |
| K151917 | ARIES System | Luminex Corporation | Oct 6, 2015 | SESE |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | Jul 16, 2015 | SESE |
| K140447 | BD VIPER LT SYSTEM | Becton, Dickinson and Company | May 20, 2014 | SESE |
| K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | Life Technologies Corporation | Mar 8, 2013 | SESE |
| K113319 | ROTOR-GENE Q MDX | QIAGEN GmbH | Feb 6, 2012 | SESE |
| K102314 | 3M INTEGRATED CYCLER (110V) & (220V) | Focus Diagnostics, Inc. | Oct 29, 2010 | SESE |
| K093383 | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG | bioMerieux, Inc. | Jul 6, 2010 | SESE |
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 | Abbott Molecular, Inc. | May 28, 2010 | SESE |
Top Applicants
- Meridian Bioscience, Inc. — 3 clearances
- Luminex Corporation — 3 clearances
- bioMerieux, Inc. — 1 clearance
- QIAGEN GmbH — 1 clearance
- Life Technologies Corporation — 1 clearance
