OOI — Real Time Nucleic Acid Amplification System Class II
Classification Details
- Product Code
- OOI
- Device Class
- Class II
- Regulation Number
- 862.2570
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243922 | meridian bioscience | Revogene | March 20, 2025 |
| K222779 | meridian bioscience | Revogene | January 26, 2023 |
| K220480 | meridian bioscience | Revogene | July 11, 2022 |
| K170558 | genepoc | revogene | May 25, 2017 |
| K161495 | luminex corporation | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 | June 30, 2016 |
| K160517 | luminex corporation | ARIES System | April 12, 2016 |
| K151917 | luminex corporation | ARIES System | October 6, 2015 |
| K151690 | alere scarborough | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | July 16, 2015 |
| K140447 | becton, dickinson and | BD VIPER LT SYSTEM | May 20, 2014 |
| K123955 | life technologies corporation | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | March 8, 2013 |
| K113319 | qiagen | ROTOR-GENE Q MDX | February 6, 2012 |
| K102314 | focus diagnostics | 3M INTEGRATED CYCLER (110V) & (220V) | October 29, 2010 |
| K093383 | biomerieux | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ | July 6, 2010 |
| K092705 | abbott molecular | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES) | May 28, 2010 |