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510(k) K221420

AlphaID™ At Home Genetic Health Risk Service by Progenika Biopharma S.A., A Grifols Company — Product Code PTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2022
Date Received
May 16, 2022
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 Progenika Biopharma S.A., A Grifols Company

  • K211115 — A1AT Genotyping Test (May 13, 2021)
  • K192858 — A1AT Genotyping Test (November 5, 2019)
  • K171868 — A1AT Genotyping Test (November 11, 2017)

Other clearances for product code PTA

  • K241456 — GlutenID Celiac Genetic Health Risk Test (January 7, 2025)
  • K192073 — Helix Genetic Health Risk App for late-onset Alzheimer’s disease (December 23, 2020)
  • 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)