Submission Details
| 510(k) Number | K192073 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Helix Genetic Health Risk App for late-onset Alzheimer?s disease
Dec 2020
Decision
509d
Days
Class 2
Risk
About This 510(k) Submission
K192073 is an FDA 510(k) clearance for the Helix Genetic Health Risk App for late-onset Alzheimer?s disease, 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 review panel. Regulated under 21 CFR 866.5950.
Device Classification
| 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 Person?s Overall Risk Of Developing A Disease. |
Manufacturer
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