DEN180028 is an FDA 510(k) submission for the 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports. This device is classified as a Direct-to-consumer Access Pharmacogenetic Assessment System (Class II - Special Controls, product code QDJ).
Submitted by 23AndMe, Inc. (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on October 31, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3364. A Direct-to-consumer Access Pharmacogenetic Assessment System Is A Qualitative In Vitro Molecular Diagnostic System Used For Detecting Variants In Nucleic Acids Isolated From Human Specimens The Purpose Of Identifying Pharmacogenetic Associations For The Detected Variants. This Device Is For In Vitro Diagnostic Use Only, And Is Intended For Direct Access Testing By Lay Users..
| 510(k) Number | DEN180028 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 05, 2018 |
| Decision Date | October 31, 2018 |
| Days to Decision | 148 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | QDJ - Direct-to-consumer Access Pharmacogenetic Assessment System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3364 |
| Definition | A Direct-to-consumer Access Pharmacogenetic Assessment System Is A Qualitative In Vitro Molecular Diagnostic System Used For Detecting Variants In Nucleic Acids Isolated From Human Specimens The Purpose Of Identifying Pharmacogenetic Associations For The Detected Variants. This Device Is For In Vitro Diagnostic Use Only, And Is Intended For Direct Access Testing By Lay Users. |