Cleared Traditional

K193492 - 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (FDA 510(k) Clearance)

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

K193492 · 23AndMe, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2020
Decision
244d
Days
Class 2
Risk

K193492 is an FDA 510(k) clearance 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. (Sunnyvale, US). The FDA issued a Cleared decision on August 17, 2020 after a review of 244 days - an extended review cycle.

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 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K193492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2019
Decision Date August 17, 2020
Days to Decision 244 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 88d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.