K231776 is an FDA 510(k) clearance for the Cell-Free DNA BCT. This device is classified as a Blood Collection Device For Cell-free Nucleic Acid (Class II - Special Controls, product code QMA).
Submitted by Streck, Inc. (La Vista, US). The FDA issued a Cleared decision on July 26, 2024, 406 days after receiving the submission on June 16, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1676. A Blood Collection Device For Cell-free Nucleic Acids Is A Device Intended For Medical Purposes To Collect, Store, Transport, And Handle Blood Specimens And To Stabilize And Isolate Cell-free Nucleic Acid Components Prior To Further Testing..
| 510(k) Number | K231776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2023 |
| Decision Date | July 26, 2024 |
| Days to Decision | 406 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | QMA - Blood Collection Device For Cell-free Nucleic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1676 |
| Definition | A Blood Collection Device For Cell-free Nucleic Acids Is A Device Intended For Medical Purposes To Collect, Store, Transport, And Handle Blood Specimens And To Stabilize And Isolate Cell-free Nucleic Acid Components Prior To Further Testing. |