K110203 is an FDA 510(k) clearance for the XPERT C. DIFFICLE/EPI ASSAY. This device is classified as a C. Difficile Nucleic Acid Amplification Test Assay (Class I - General Controls, product code OMN).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on April 7, 2011, 73 days after receiving the submission on January 24, 2011.
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 | K110203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2011 |
| Decision Date | April 07, 2011 |
| Days to Decision | 73 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. |