FDA.reportPublic FDA data

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

Primary DI
00859462006392
Brand
23andMe, Inc. Personal Genome Service®(PGS)
Company
23ANDME GENOMICS LLC
Model
YouDot
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, and Medication Insights Reports, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related)
Published
2023-03-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System
PTAGenetic Variant Detection And Health Risk Assessment System
QAZCancer Predisposition Risk Assessment System
QDJDirect-To-Consumer Access Pharmacogenetic Assessment System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKBAutosomal Recessive Carrier Screening Gene Mutation Detection SystemImmunology2
PTAGenetic Variant Detection And Health Risk Assessment SystemImmunology2
QAZCancer Predisposition Risk Assessment SystemMedical Genetics2
QDJDirect-To-Consumer Access Pharmacogenetic Assessment SystemMedical Genetics2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140044000
DEN160026000
DEN170046000
DEN180028000
K182784000
K193492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN14004400023ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)23AndMe2015-02-19PKB
DEN16002600023andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia23AndMe, Inc.2017-04-06PTA
DEN17004600023andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23AndMe, Inc.2018-03-06QAZ
DEN18002800023andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc.2018-10-31QDJ
K182784000MUTYH-Associated Polyposis (MAP)23AndMe, Inc.2019-01-18QAZ
K19349200023andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc.2020-08-17QDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859462006392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859462006392008594620063928594620063920859462006392

GMDN Terms#

Term, Definition table
TermDefinition
Human genomic analysis interpretive softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144889067
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085946200602623andMe, Inc. Personal Genome Service®(PGS)YouDotn/a2017-04-17
0085946200641523andMe, Inc. Personal Genome Service®(PGS)YouDot2023-10-16
0085946200640823andMe, Inc. Personal Genome Service®(PGS)YouDot2023-07-19
0085946200638523andMe, Inc. Personal Genome Service®(PGS)YouDot2023-01-25
0085946200637823andMe, Inc. Personal Genome Service®(PGS)YouDot2022-05-24
0085946200626223andMe, Inc. Personal Genome Service®(PGS)YouDot2021-05-19
0085946200627923andMe, Inc. Personal Genome Service®(PGS)YouDot2020-03-09
0085946200611823andMe, Inc. Personal Genome Service®(PGS)YouDotn/a2019-06-27
0085946200609523andMe, Inc. Personal Genome Service®(PGS)YouDotn/a2018-07-17
0086215000006023andMe, Inc. Personal Genome Service®YouDot (Carrier)2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013485405Targeted Genomics, LLCGENOMECONSULT, LLCPTA2025-03-21
0085946200641523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2023-10-16
0085946200641523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQDJ2023-10-16
0085946200641523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQAZ2023-10-16
0085946200641523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-10-16
0085946200640823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2023-07-19
0085946200640823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQDJ2023-07-19
0085946200640823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQAZ2023-07-19
0085946200640823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-07-19
08437013457095A1AT Genotyping TestPROGENIKA BIOPHARMA, SAPTA2023-07-14
08437013457101A1AT Genotyping TestPROGENIKA BIOPHARMA, SAPTA2023-07-14
0085946200638523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQDJ2023-01-25
0085946200638523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-01-25
0085946200638523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2023-01-25
0085946200638523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQAZ2023-01-25
0085946200637823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2022-05-24
0085946200637823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQAZ2022-05-24
0085946200637823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2022-05-24
0085946200637823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQDJ2022-05-24
0085946200626223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2021-05-19
0085946200626223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQDJ2021-05-19
0085946200626223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQAZ2021-05-19
0085946200626223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2021-05-19
0085946200627923andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQDJ2020-03-09
0085946200627923andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQAZ2020-03-09
0085946200627923andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2020-03-09
0085946200627923andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2020-03-09
0085946200611823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2019-06-27
0085946200611823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCQAZ2019-06-27
0085946200611823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2019-06-27