Revogene
FDA 510(k) K220480 · Meridian Bioscience, Inc.
510(k) numberK220480
Submission
- Device name
- Revogene
- Applicant
- Meridian Bioscience, Inc.
Cincinnati, OH, US - Received
- February 18, 2022
- Decision date
- July 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOI – Real Time Nucleic Acid Amplification System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2570
- Specialty
- Clinical Chemistry
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…
Other 510(k)s with product code OOI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243922 | RevogeneOOI · Traditional | Meridian Bioscience, Inc. | 03/20/2025SE |
| K222779 | RevogeneOOI · Special | Meridian Bioscience, Inc. | 01/26/2023SE |
| K170558 | revogeneOOI · Traditional | Genepoc, Inc. | 05/25/2017SE |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay…OOI · Special | Luminex Corporation | 06/30/2016SE |
| K160517 | ARIES SystemOOI · Special | Luminex Corporation | 04/12/2016SE |
| K151917 | ARIES SystemOOI · Traditional | Luminex Corporation | 10/06/2015SE |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep AOOI · Special | Alere Scarborough, Inc. | 07/16/2015SE |
| K140447 | BD Viper LT SystemOOI · Traditional | Becton, Dickinson and Company | 05/20/2014SE |
| K123955 | Quantstudio DX Real-Time PCR InstrumentOOI · Traditional | Life Technologies Corporation | 03/08/2013SE |
| K113319 | Rotor-Gene Q MDXOOI · Traditional | QIAGEN GmbH | 02/06/2012SE |
More from QIAGEN GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K243922 | RevogeneOOI · Traditional | 03/20/2025SE |
| K230901 | Premier HpSA Flex (619096)LYR · Traditional | 07/03/2023SE |
| K222829 | Curian® Shiga ToxinGMZ · Traditional | 04/17/2023SE |
| K222779 | RevogeneOOI · Special | 01/26/2023SE |
| K210976 | Curian CampyLQP · Traditional | 12/23/2021SE |
| K192817 | Curian HpSA, Curian AnalyzerLYR · Traditional | 03/13/2020SE |
| K182559 | PREMIER Platinum HpSA PLUSLYR · Traditional | 11/05/2018SE |
| K163273 | TRU LegionellaMJH · Special | 02/21/2017SE |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct…OZX · Traditional | 06/13/2016SE |
| K153661 | ImmunoCard STAT! HpSALYR · Traditional | 03/14/2016SE |
Questions and answers
When was Revogene cleared by the FDA?
Revogene (K220480) received a 510(k) decision of Substantially Equivalent on July 11, 2022, 143 days after the submission was received.
What is the product code of K220480?
The FDA product code is OOI – Real Time Nucleic Acid Amplification System, a Class II (moderate risk) device regulated under 21 CFR 862.2570.