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510(k) K192073

Helix Genetic Health Risk App for late-onset Alzheimer’s disease by Helix Opco, LLC — Product Code PTA

K192073 is an FDA 510(k) premarket notification submitted by Helix Opco, LLC for the device "Helix Genetic Health Risk App for late-onset Alzheimer’s disease". The FDA issued a decision of Substantially Equivalent on December 23, 2020. The device falls under product code PTA (Genetic Variant Detection And Health Risk Assessment System), a Class II device regulated under 21 CFR 866.5950. Helix Opco, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2020
Date Received
August 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Genetic Variant Detection And Health Risk Assessment System
Device Class
Class II
Regulation Number
866.5950
Review Panel
IM
Submission Type

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.

Other clearances by Helix Opco, LLC

  • DEN190035 — Helix Laboratory Platform (December 23, 2020)

Other clearances for product code PTA

  • K241456 — GlutenID Celiac Genetic Health Risk Test (January 7, 2025)
  • K221420 — AlphaID™ At Home Genetic Health Risk Service (October 27, 2022)
  • K192944 — AncestryDNA Factor V Leiden Genetic Health Risk Test (August 13, 2020)
  • DEN160026 — 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Th (April 6, 2017)

FDA data resources