K190463 is an FDA 510(k) clearance for the Cepheid Xpert C. difficile/Epi Control Panel. This device is classified as a Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (Class II - Special Controls, product code PMN).
Submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on April 19, 2019, 52 days after receiving the submission on February 26, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3920. Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use..
| 510(k) Number | K190463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2019 |
| Decision Date | April 19, 2019 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PMN — Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3920 |
| Definition | Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use. |