K193492 is an FDA 510(k) clearance 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. (Sunnyvale, US). The FDA issued a Cleared decision on August 17, 2020, 244 days after receiving the submission on December 17, 2019.
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 | K193492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2019 |
| Decision Date | August 17, 2020 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| 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. |