Definition: A Qualitative In Vitro Molecular Test That Detects Variants In Genomic DNA Isolated From Human Specimens. This Assessment System Provides Users With A Genetic Health Risk Assessment Of Developing A Disease And Is Intended To Inform Users Of Lifestyle
| Device Type ID | 3107 |
| Device Name | Genetic Variant Detection And Health Risk Assessment System |
| Physical State | Qualitative In Vitro Molecular Diagnostic System Used To Detect Variants In Genomic DNA From Human Specimens. System Accessory Includes Collection Device For Human Specimen. |
| Technical Method | Qualitative In Vitro Molecular Diagnostic System Used To Detect Variants In Genomic DNA Isolated From Human Specimens. Genetic Risk Assessment Of Developing A Disease Is Based On Scientifically Established Disease-risk Association For Each Variant. |
| Target Area | Human Specimens Collected By The User. |
| Regulation Description | Genetic Health Risk Assessment System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.5950 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3107 |
| Device | Genetic Variant Detection And Health Risk Assessment System |
| Product Code | PTA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Genetic Health Risk Assessment System. |
| CFR Regulation Number | 866.5950 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
23ANDME, INC. | ||
GRANTED | 1 | |