Not Cleared Direct

DEN180028 - 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (FDA 510(k) Clearance)

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

DEN180028 · 23AndMe, Inc. · Chemistry device
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Oct 2018
Decision
148d
Days
Class 2
Risk

DEN180028 is an FDA 510(k) submission (not cleared) for the 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports. Classified as Direct-to-consumer Access Pharmacogenetic Assessment System (product code QDJ), Class II - Special Controls.

Submitted by 23AndMe, Inc. (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on October 31, 2018 after a review of 148 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3364 - the FDA in vitro diagnostics and chemistry 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

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Submission Details

510(k) Number DEN180028 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 05, 2018
Decision Date October 31, 2018
Days to Decision 148 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 88d · This submission: 148d
Pathway characteristics

Device Classification

Product Code QDJ Direct-to-consumer Access Pharmacogenetic Assessment System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3364
Definition A Direct-to-consumer Access Pharmacogenetic Assessment System Is A Qualitative In Vitro Molecular Diagnostic System Used For Detecting Variants In Nucleic Acids Isolated From Human Specimens The Purpose Of Identifying Pharmacogenetic Associations For The Detected Variants. This Device Is For In Vitro Diagnostic Use Only, And Is Intended For Direct Access Testing By Lay Users.
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 Chemistry devices follow this clearance model.