Not Cleared Direct

DEN160026 - 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia (FDA 510(k) Clearance)

Class II Hematology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160026 · 23AndMe, Inc. · Hematology device
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Apr 2017
Decision
282d
Days
Class 2
Risk

DEN160026 is an FDA 510(k) submission (not cleared) for the 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary.... Classified as Genetic Variant Detection And Health Risk Assessment System (product code PTA), Class II - Special Controls.

Submitted by 23AndMe, Inc. (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on April 6, 2017 after a review of 282 days.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.5950 - the FDA hematology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 282 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN160026 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 28, 2016
Decision Date April 06, 2017
Days to Decision 282 days
Submission Type Direct
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 113d · This submission: 282d
Pathway characteristics

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 Hematology devices follow this clearance model.