Genetic Variant Detection And Health Risk Assessment System
The Genetic Variant Detection and Health Risk Assessment System is a qualitative in vitro molecular test that detects variants in genomic DNA from human specimens to provide users with a genetic health risk assessment of developing certain diseases, intended for over-the-counter use to inform lifestyle choices and encourage conversations with healthcare professionals. It is classified as FDA Class 2 under 21 CFR 866.5950 in the Immunology specialty, exempt from 510(k) premarket notification requirements (de novo or notification exemption). The device does not determine an individual's overall disease risk. Product code PTA; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PTA
- Device Class
- FDA class 2
- Regulation Number
- 866.5950
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241456 | GlutenID Celiac Genetic Health Risk Test | Jan 07, 2025 | Substantially Equivalent | Targeted Genomics, LLC |
| K221420 | AlphaID At Home Genetic Health Risk Service | Oct 27, 2022 | Substantially Equivalent | Progenika Biopharma S.A., A Grifols Company |
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimers disease | Dec 23, 2020 | Substantially Equivalent | Helix Opco, LLC |
| K192944 | AncestryDNA Factor V Leiden Genetic Health Risk Test | Aug 13, 2020 | Substantially Equivalent | Ancestry Genomics, Inc. |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | Apr 06, 2017 | Unknown | 23AndMe, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.