FDA product code OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay
OZE is the FDA product code for influenza a and influenza b multiplex nucleic acid assay. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. FDA has cleared 20 510(k) submissions under OZE, 5 in the last five years, from 9 different applicants. The average 510(k) review took 74 days (median 37); 102 days on average over the last three years. FDA has posted 5 recalls for OZE devices, 4 initiated in the last five years.
Definition
An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| 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 OZE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2018 | 2 | 138 |
| 2019 | 3 | 102 |
| 2020 | 1 | 25 |
| 2022 | 1 | 98 |
| 2023 | 1 | 32 |
| 2024 | 1 | 29 |
| 2025 | 2 | 176 |
Compare with all 510(k) review times · Search every OZE clearance
Top OZE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centers for Disease Control and Prevention | 9 | 2025-07-11 |
| Centers For Disease Control and Prevention (CDC) | 3 | 2018-07-30 |
| Quidel Corp. | 2 | 2013-08-29 |
| Quidel Corporation | 1 | 2023-03-03 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 2022-06-24 |
4 more applicants have OZE clearances. See the full list in Caduvo.
Most recent OZE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243274 | Centers for Disease Control and Prevention | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | 2025-07-11 | 268 |
| K243931 | Centers for Disease Control and Prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | 2025-03-14 | 84 |
| K241110 | Centers for Disease Control and Prevention | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) | 2024-05-21 | 29 |
| K230236 | Quidel Corporation | Lyra Influenza A+B Assay | 2023-03-03 | 32 |
| K220801 | Abbott Diagnostics Scarborough, Inc. | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | 2022-06-24 | 98 |
Recalls for OZE devices
5 product recalls in 5 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-02-09.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code OZE?
OZE is the FDA product code for influenza a and influenza b multiplex nucleic acid assay. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OZE?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZE?
Across 20 cleared submissions the average was 74 days from receipt to decision (median 37).
Which companies have the most OZE clearances?
Centers for Disease Control and Prevention (9); Centers For Disease Control and Prevention (CDC) (3); Quidel Corp. (2); Quidel Corporation (1); Abbott Diagnostics Scarborough, Inc. (1).
Have OZE devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2026-02-09.
Next steps
- Run an FDA pathway report with predicate devices for product code OZE
- Run a recall and safety report across every OZE manufacturer
- Watch product code OZE 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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