Cleared Traditional

Helix Genetic Health Risk App for late-onset Alzheimer’s disease (K192073) - FDA 510(k) Clearance

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

K192073 · Helix Opco, LLC · Immunology device
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Dec 2020
Decision
509d
Days
Class 2
Risk

K192073 is an FDA 510(k) clearance for the Helix Genetic Health Risk App for late-onset Alzheimer’s disease. Classified as Genetic Variant Detection And Health Risk Assessment System (product code PTA), Class II - Special Controls.

Submitted by Helix Opco, LLC (Toronto, CA). The FDA issued a Cleared decision on December 23, 2020 after a review of 509 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Helix Opco, LLC devices

Submission Details

510(k) Number K192073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2019
Decision Date December 23, 2020
Days to Decision 509 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
405d slower than avg
Panel avg: 104d · This submission: 509d
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.

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