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
| Device Type ID | 691 |
| Device Name | Direct-to-consumer Access Pharmacogenetic Assessment System |
| Physical State | The Test System Includes Reagents And Instrumentation For Measuring And Analyzing Nucleic Acid Sequences And Methods For Interpretation Of The Pharmacogenetic Associations For Detected Nucleic Acid Sequence Variations. The Test System Provides Inform |
| Technical Method | Measures And Analyzes Nucleic Acid Sequences And Interprets Pharmacogenetic Associations For Detected Nucleic Acid Sequence Variations. |
| Target Area | Sample Collection Device, Molecular Diagnostic Test |
| Regulation Medical Specialty | Molecular Genetics |
| Review Panel | Clinical Chemistry |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3364 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 691 |
| Device | Direct-to-consumer Access Pharmacogenetic Assessment System |
| Product Code | QDJ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.3364 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
23ANDME, INC. | ||
GRANTED | 1 | |