K191168 is an FDA 510(k) clearance for the Cepheid Xpert SA Nasal Complete 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 June 25, 2019, 55 days after receiving the submission on May 1, 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 | K191168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2019 |
| Decision Date | June 25, 2019 |
| Days to Decision | 55 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. |