FDA product code OCC: Respiratory Virus Panel Nucleic Acid Assay System
OCC is the FDA product code for respiratory virus panel nucleic acid assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. FDA has cleared 79 510(k) submissions under OCC, 6 in the last five years, from 30 different applicants. The average 510(k) review took 97 days (median 85); 54 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 25 recalls for OCC devices, 6 initiated in the last five years.
Definition
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.
Classification
| Field | Value |
|---|---|
| Device name | Respiratory Virus Panel Nucleic Acid Assay System |
| Device class | Class II |
| Regulation | 21 CFR 866.3980 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for OCC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 10 | 145 |
| 2018 | 4 | 120 |
| 2019 | 5 | 67 |
| 2020 | 2 | 53 |
| 2021 | 1 | 19 |
| 2022 | 1 | 210 |
| 2023 | 2 | 27 |
| 2024 | 1 | 29 |
| 2026 | 2 | 79 |
Compare with all 510(k) review times · Search every OCC clearance
Top OCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luminex Molecular Diagnostics, Inc. | 8 | 2024-10-02 |
| Cepheid | 8 | 2018-08-15 |
| Nanosphere, Inc. | 6 | 2015-09-04 |
| Alere Scarborough, Inc. | 5 | 2018-01-26 |
| Hologic, Inc. | 4 | 2023-05-05 |
25 more applicants have OCC clearances. See the full list in Caduvo.
Most recent OCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262747 | Abbott Diagnostics Scarborough, Inc. | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | 2026-08-31 | 28 |
| K254139 | Applied BioCode, Inc. | BioCode® Respiratory Pathogen Panel (RPP) | 2026-05-01 | 130 |
| K242613 | Luminex Molecular Diagnostics, Inc. | NxTAG® Respiratory Pathogen Panel | 2024-10-02 | 29 |
| K232775 | Abbott Diagnostics Scarborough, Inc. | ID NOW Influenza A & B 2 | 2023-10-10 | 29 |
| K231017 | Hologic, Inc. | Panther Fusion AdV/hMPV/RV Assay | 2023-05-05 | 25 |
Recalls for OCC devices
25 product recalls in 20 recall events; 6 initiated in the last five years and 15 still open. Most recent: 2025-04-30.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 6 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code OCC?
OCC is the FDA product code for respiratory virus panel nucleic acid assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OCC?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCC?
Across 79 cleared submissions the average was 97 days from receipt to decision (median 85).
Which companies have the most OCC clearances?
Luminex Molecular Diagnostics, Inc. (8); Cepheid (8); Nanosphere, Inc. (6); Alere Scarborough, Inc. (5); Hologic, Inc. (4).
Have OCC devices been recalled?
Yes: 25 product recalls across 20 recall events; the most recent began 2025-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code OCC
- Run a recall and safety report across every OCC manufacturer
- Watch product code OCC 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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