Cleared Traditional

AlphaID? At Home Genetic Health Risk Service

K221420 · Progenika Biopharma S.A., A Grifols Company · Immunology

Oct 2022

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K221420 is an FDA 510(k) clearance for the AlphaID? At Home Genetic Health Risk Service, a Genetic Variant Detection And Health Risk Assessment System (Class II — Special Controls, product code PTA), submitted by Progenika Biopharma S.A., A Grifols Company (Derio, ES). The FDA issued a Cleared decision on October 27, 2022, 164 days after receiving the submission on May 16, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5950.

Submission Details

510(k) Number	K221420 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2022
Decision Date	October 27, 2022
Days to Decision	164 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

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.