FDA product code OZN: C. Difficile Toxin Gene Amplification Assay
OZN is the FDA product code for c. difficile toxin gene amplification assay. It is a Class II device, regulated under 21 CFR 866.3130 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under OZN, 3 in the last five years, from 13 different applicants. The average 510(k) review took 106 days (median 88); 160 days on average over the last three years. FDA has posted 8 recalls for OZN devices, 5 initiated in the last five years.
Definition
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Classification
| Field | Value |
|---|---|
| Device name | C. Difficile Toxin Gene Amplification Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3130 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for OZN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 86 |
| 2021 | 2 | 144 |
| 2023 | 1 | 124 |
| 2025 | 1 | 87 |
| 2026 | 1 | 233 |
Compare with all 510(k) review times · Search every OZN clearance
Top OZN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Molecular Systems, Inc. | 5 | 2026-08-28 |
| Quidel Corporation | 2 | 2017-05-11 |
| Cepheid® | 1 | 2025-02-28 |
| Vela Operations USA | 1 | 2023-11-14 |
| Genepoc, Inc. | 1 | 2017-11-22 |
8 more applicants have OZN clearances. See the full list in Caduvo.
Most recent OZN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260045 | Roche Molecular Systems, Inc. | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | 2026-08-28 | 233 |
| K243730 | Cepheid® | Xpert C. difficile/Epi | 2025-02-28 | 87 |
| K232092 | Vela Operations USA | Great Basin Toxigenic C. difficile Direct Test (CDF2) | 2023-11-14 | 124 |
| K212427 | Roche Molecular Systems, Inc. | cobas Cdiff nucleic acid test for use on the cobas Liat System | 2021-10-20 | 77 |
| K210385 | Roche Molecular Systems, Inc. | cobas Cdiff nucleic acid test for use on the cobas Liat System | 2021-09-09 | 212 |
Recalls for OZN devices
8 product recalls in 8 recall events; 5 initiated in the last five years and 6 still open. Most recent: 2025-12-05.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code OZN?
OZN is the FDA product code for c. difficile toxin gene amplification assay. It is a Class II device, regulated under 21 CFR 866.3130 and reviewed by the Microbiology panel.
What device class is OZN?
Class II, regulation 21 CFR 866.3130. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZN?
Across 18 cleared submissions the average was 106 days from receipt to decision (median 88).
Which companies have the most OZN clearances?
Roche Molecular Systems, Inc. (5); Quidel Corporation (2); Cepheid® (1); Vela Operations USA (1); Genepoc, Inc. (1).
Have OZN devices been recalled?
Yes: 8 product recalls across 8 recall events; the most recent began 2025-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code OZN
- Run a recall and safety report across every OZN manufacturer
- Watch product code OZN 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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