Cleared Traditional

K221420 - AlphaID™ At Home Genetic Health Risk Service (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221420 · Progenika Biopharma S.A., A Grifols Company · Immunology device
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Oct 2022
Decision
164d
Days
Class 2
Risk

K221420 is an FDA 510(k) clearance for the AlphaID™ At Home Genetic Health Risk Service. Classified as Genetic Variant Detection And Health Risk Assessment System (product code PTA), Class II - Special Controls.

Submitted by Progenika Biopharma S.A., A Grifols Company (Derio, ES). The FDA issued a Cleared decision on October 27, 2022 after a review of 164 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5950 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Progenika Biopharma S.A., A Grifols Company devices

Submission Details

510(k) Number K221420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 104d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PTA Genetic Variant Detection And Health Risk Assessment System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.