K100818 is an FDA 510(k) clearance for the ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920. This device is classified as a C. Difficile Nucleic Acid Amplification Test Assay (Class I - General Controls, product code OMN).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 9, 2010, 108 days after receiving the submission on March 23, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660. 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) Number | K100818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2010 |
| Decision Date | July 09, 2010 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OMN — C. Difficile Nucleic Acid Amplification Test Assay |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |
| 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. |