FDA product code OOI: Real Time Nucleic Acid Amplification System
OOI is the FDA product code for real time nucleic acid amplification system. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel. FDA has cleared 14 510(k) submissions under OOI, 3 in the last five years, from 10 different applicants. The average 510(k) review took 106 days (median 88); 90 days on average over the last three years. FDA has posted 30 recalls for OOI devices, 16 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Real Time Nucleic Acid Amplification System |
| Device class | Class II |
| Regulation | 21 CFR 862.2570 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for OOI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2022 | 1 | 143 |
| 2023 | 1 | 134 |
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every OOI clearance
Top OOI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 3 | 2025-03-20 |
| Luminex Corporation | 3 | 2016-06-30 |
| Genepoc, Inc. | 1 | 2017-05-25 |
| Alere Scarborough, Inc. | 1 | 2015-07-16 |
| Becton, Dickinson and Company | 1 | 2014-05-20 |
5 more applicants have OOI clearances. See the full list in Caduvo.
Most recent OOI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243922 | Meridian Bioscience, Inc. | Revogene | 2025-03-20 | 90 |
| K222779 | Meridian Bioscience, Inc. | Revogene | 2023-01-26 | 134 |
| K220480 | Meridian Bioscience, Inc. | Revogene | 2022-07-11 | 143 |
| K170558 | Genepoc, Inc. | revogene | 2017-05-25 | 90 |
| K161495 | Luminex Corporation | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) | 2016-06-30 | 29 |
Recalls for OOI devices
30 product recalls in 30 recall events; 16 initiated in the last five years and 15 still open. Most recent: 2025-03-20.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 7 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code OOI?
OOI is the FDA product code for real time nucleic acid amplification system. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel.
What device class is OOI?
Class II, regulation 21 CFR 862.2570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OOI?
Across 14 cleared submissions the average was 106 days from receipt to decision (median 88).
Which companies have the most OOI clearances?
Meridian Bioscience, Inc. (3); Luminex Corporation (3); Genepoc, Inc. (1); Alere Scarborough, Inc. (1); Becton, Dickinson and Company (1).
Have OOI devices been recalled?
Yes: 30 product recalls across 30 recall events; the most recent began 2025-03-20.
Next steps
- Run an FDA pathway report with predicate devices for product code OOI
- Run a recall and safety report across every OOI manufacturer
- Watch product code OOI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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