FDA product code OMN: C. Difficile Nucleic Acid Amplification Test Assay
OMN is the FDA product code for c. difficile nucleic acid amplification test assay. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under OMN, from 3 different applicants. The average 510(k) review took 92 days (median 90). 1 De Novo request was granted under it. FDA has posted 2 recalls for OMN devices, 1 initiated in the last five years.
Definition
In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.
Classification
| Field | Value |
|---|---|
| Device name | C. Difficile Nucleic Acid Amplification Test Assay |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OMN clearance
Top OMN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 2 | 2011-02-24 |
| Focus Diagnostics, Inc. | 1 | 2012-04-04 |
| Cepheid | 1 | 2011-04-07 |
Most recent OMN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113433 | Focus Diagnostics, Inc. | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | 2012-04-04 | 135 |
| K110203 | Cepheid | XPERT C. DIFFICLE/EPI ASSAY | 2011-04-07 | 73 |
| K110012 | Meridian Bioscience, Inc. | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | 2011-02-24 | 52 |
| K100818 | Meridian Bioscience, Inc. | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 | 2010-07-09 | 108 |
Recalls for OMN devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-07.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code OMN?
OMN is the FDA product code for c. difficile nucleic acid amplification test assay. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is OMN?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OMN?
Across 4 cleared submissions the average was 92 days from receipt to decision (median 90).
Which companies have the most OMN clearances?
Meridian Bioscience, Inc. (2); Focus Diagnostics, Inc. (1); Cepheid (1).
Have OMN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-10-07.
Next steps
- Run an FDA pathway report with predicate devices for product code OMN
- Run a recall and safety report across every OMN manufacturer
- Watch product code OMN 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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