FDA product code OZZ: Bordetella Pertussis Dna Assay System
OZZ is the FDA product code for bordetella pertussis dna assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under OZZ, 1 in the last five years, from 6 different applicants. The average 510(k) review took 130 days (median 90); 350 days on average over the last three years. FDA has posted 2 recalls for OZZ devices, 1 initiated in the last five years.
Definition
A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Classification
| Field | Value |
|---|---|
| Device name | Bordetella Pertussis Dna 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 OZZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 96 |
| 2018 | 3 | 130 |
| 2025 | 1 | 350 |
Compare with all 510(k) review times · Search every OZZ clearance
Top OZZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diasorin Molecular, LLC | 2 | 2018-12-19 |
| Quidel Corporation | 2 | 2018-07-15 |
| Meridian Bioscience, Inc. | 2 | 2015-11-10 |
| Roche Molecular Systems, Inc. | 1 | 2025-11-20 |
| Luminex Corporation | 1 | 2017-05-02 |
1 more applicants have OZZ clearances. See the full list in Caduvo.
Most recent OZZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243753 | Roche Molecular Systems, Inc. | cobas liat Bordetella panel nucleic acid test | 2025-11-20 | 350 |
| K183223 | Diasorin Molecular, LLC | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | 2018-12-19 | 29 |
| K173498 | Diasorin Molecular, LLC | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | 2018-08-13 | 273 |
| K181029 | Quidel Corporation | Solana Bordetella Complete Assay | 2018-07-15 | 88 |
| K163626 | Luminex Corporation | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | 2017-05-02 | 131 |
Recalls for OZZ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2025-03-24.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code OZZ?
OZZ is the FDA product code for bordetella pertussis dna assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OZZ?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZZ?
Across 9 cleared submissions the average was 130 days from receipt to decision (median 90).
Which companies have the most OZZ clearances?
Diasorin Molecular, LLC (2); Quidel Corporation (2); Meridian Bioscience, Inc. (2); Roche Molecular Systems, Inc. (1); Luminex Corporation (1).
Have OZZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-03-24.
Next steps
- Run an FDA pathway report with predicate devices for product code OZZ
- Run a recall and safety report across every OZZ manufacturer
- Watch product code OZZ 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times