K231221 is an FDA 510(k) clearance for the MDx-Chex for BC-GP. 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 Streck (La Vista, US). The FDA issued a Cleared decision on July 27, 2023, 90 days after receiving the submission on April 28, 2023.
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 | K231221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2023 |
| Decision Date | July 27, 2023 |
| Days to Decision | 90 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. |