Genetic Variant Detection And Health Risk Assessment System
Immunology · 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.
Recent MDR events
7 adverse event reports on file
- ConquestApr 13, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-00920
- HIGH THROUGHPUT DNA SEQUENCE ANALYZERFeb 9, 2026MalfunctionSequencing Inc.MW5183582
- GENOME DISCOVERY WGS BUNDLEAug 9, 2024MalfunctionSequencing Inc.MW5158298
- NUTRIGENOMICS AND LIFESTYLE / FITNESS / WELLNESS AND LIFESTYLE REPORTSApr 29, 2020MalfunctionUnkMW5094322
- METABOLISM+ TESTMar 31, 2020MalfunctionUnkMW5094002
- MYGENOME (30X WHOLE GENOME SEQUENCING)Mar 20, 2020MalfunctionUnkMW5093888
- MAYO CLINIC GENEGUIDE HELIXMar 20, 2020MalfunctionUnkMW5093889
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Targeted Genomics, LLCJan 7, 2025
K241456 · GlutenID Celiac Genetic Health Risk Test
- Progenika Biopharma S.A., A Grifols CompanyOct 27, 2022
K221420 · AlphaID At Home Genetic Health Risk Service
- Helix Opco, LLCDec 23, 2020
K192073 · Helix Genetic Health Risk App for late-onset Alzheimers disease
- Ancestry Genomics, Inc.Aug 13, 2020
K192944 · AncestryDNA Factor V Leiden Genetic Health Risk Test
- 23AndMe, Inc.Apr 6, 2017
DEN160026 · 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia