23andMe, Inc. Personal Genome Service®(PGS)

Basic Information

• Brand Name: 23andMe, Inc. Personal Genome Service®(PGS)
• Primary DI: 00859462006415
• Version / Model: YouDot
• Company Name: 23ANDME, INC.
• Labeler DUNS: 780119710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-16
• Public Version: 1
• Public Version Date: 2023-10-24
• Public Version Status: New
• Public Device Record Key: 8b11e21e-300b-4070-bcf6-674696a8e73d

Device Description

23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, CYP2C19 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight, BRCA1/BRCA2 (Selected Variants) report update

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PKB	Autosomal Recessive Carrier Screening Gene Mutation Detection System	Immunology	866.5940	2
QDJ	Direct-To-Consumer Access Pharmacogenetic Assessment System	Medical Genetics	862.3364	2
QAZ	Cancer Predisposition Risk Assessment System	Medical Genetics	866.6090	2
PTA	Genetic Variant Detection And Health Risk Assessment System	Immunology	866.5950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61777	Human genomic analysis interpretive software	An interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile. This software is not an IVD device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859462006415	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN140044	000
DEN160026	000
DEN170046	000
DEN180028	000
K182784	000
K193492	000