K200010 is an FDA 510(k) clearance for the FilmArray BCID2 Control Panel M416. 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 Maine Molecular Quality Controls, Inc. (Saco, US). The FDA issued a Cleared decision on April 2, 2020, 91 days after receiving the submission on January 2, 2020.
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 | K200010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2020 |
| Decision Date | April 02, 2020 |
| Days to Decision | 91 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. |