Not Cleared Direct

DEN140044 - 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) (FDA 510(k) Clearance)

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

DEN140044 · 23AndMe · Chemistry device
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Feb 2015
Decision
266d
Days
Class 2
Risk

DEN140044 is an FDA 510(k) submission (not cleared) for the 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS). Classified as Autosomal Recessive Carrier Screening Gene Mutation Detection System (product code PKB), Class II - Special Controls.

Submitted by 23AndMe (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on February 19, 2015 after a review of 266 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5940 - 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: Regulatory edge-case submission. Elevated predicate reliance profile. With 266 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 DEN140044 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 29, 2014
Decision Date February 19, 2015
Days to Decision 266 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 88d · This submission: 266d
Pathway characteristics

Device Classification

Product Code PKB Autosomal Recessive Carrier Screening Gene Mutation Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5940
Definition Autosomal Recessive Carrier Screening Gene Mutation Detection System Is A Qualitative In Vitro Molecular Diagnostic System Used For Genotyping Of Clinically Relevant Variants In Genomic Dna Isolated From Human Peripheral Whole Blood Or Saliva Specimens Intended For Prescription Use Or Over-the-counter Use. The Device Is Intended For Autosomal Recessive Disease Carrier Screening In Adults Of Reproductive Age. The Device Is Not Intended For Copy Number Variation, Cytogenetic, Or Biochemical Testing.
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.