DEN200001 is an FDA 510(k) submission 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 Not Cleared (DENG) decision on August 7, 2020.
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 | DEN200001 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 10, 2020 |
| Decision Date | August 07, 2020 |
| Days to Decision | 210 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| 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. |