Cleared Traditional

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

K193492 · 23AndMe, Inc. · Chemistry

Aug 2020

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K193492 is an FDA 510(k) clearance for the 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports, a Direct-to-consumer Access Pharmacogenetic Assessment System (Class II — Special Controls, product code QDJ), submitted by 23AndMe, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 17, 2020, 244 days after receiving the submission on December 17, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3364.

Submission Details

510(k) Number	K193492 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	QDJ — Direct-to-consumer Access Pharmacogenetic Assessment System
Device Class	Class II — 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.