K192073 is an FDA 510(k) clearance for the Helix Genetic Health Risk App for late-onset Alzheimer’s disease. This device is classified as a Genetic Variant Detection And Health Risk Assessment System (Class II - Special Controls, product code PTA).
Submitted by Helix Opco, LLC (Toronto, CA). The FDA issued a Cleared decision on December 23, 2020, 509 days after receiving the submission on August 2, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5950. 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 Choices And/or Encourage Conversations With A Healthcare Professional. This Assessment System Is For Over-the-counter Use. This Device Does Not Determine The Persons Overall Risk Of Developing A Disease..
| 510(k) Number | K192073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2019 |
| Decision Date | December 23, 2020 |
| Days to Decision | 509 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | PTA - Genetic Variant Detection And Health Risk Assessment System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5950 |
| 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 Choices And/or Encourage Conversations With A Healthcare Professional. This Assessment System Is For Over-the-counter Use. This Device Does Not Determine The Persons Overall Risk Of Developing A Disease. |