C. Difficile Nucleic Acid Amplification Test Assay
The C. Difficile Nucleic Acid Amplification Test Assay (product code OMN) is a Class 1 in vitro diagnostic device regulated under 21 CFR 866.2660 in the Microbiology specialty (MI), exempt from premarket notification under the general controls framework. It is an in vitro diagnostic test for the qualitative detection of toxigenic Clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OMN
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN120013 | PORTRAIT ANALYZER | Apr 30, 2012 | Unknown | Great Basin Scientific |
| K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | Apr 04, 2012 | Substantially Equivalent | Focus Diagnostics, Inc. |
| K110203 | XPERT C. DIFFICLE/EPI ASSAY | Apr 07, 2011 | Substantially Equivalent | Cepheid |
| K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | Feb 24, 2011 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 | Jul 09, 2010 | Substantially Equivalent | Meridian Bioscience, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.