OMN · C. Difficile Nucleic Acid Amplification Test Assay
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | OMN |
|---|---|
| Device Name | C. Difficile Nucleic Acid Amplification Test Assay |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN120013 | PORTRAIT ANALYZER | Great Basin Scientific | Apr 30, 2012 | DENG |
| K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | Focus Diagnostics, Inc. | Apr 4, 2012 | SESE |
| K110203 | XPERT C. DIFFICLE/EPI ASSAY | Cepheid | Apr 7, 2011 | SESE |
| K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | Meridian Bioscience, Inc. | Feb 24, 2011 | SESE |
| K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 | Meridian Bioscience, Inc. | Jul 9, 2010 | SESE |
Top Applicants
- Meridian Bioscience, Inc. — 2 clearances
- Cepheid — 1 clearance
- Focus Diagnostics, Inc. — 1 clearance
- Great Basin Scientific — 1 clearance
