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510(k) K193492

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports by 23AndMe, Inc. — Product Code QDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2020
Date Received
December 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Direct-To-Consumer Access Pharmacogenetic Assessment System
Device Class
Class II
Regulation Number
862.3364
Review Panel
CH
Submission Type

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.

Other clearances by 23AndMe, Inc.

  • K223597 — 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BR (August 31, 2023)
  • K221885 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (October 26, 2022)
  • K211499 — 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) (January 6, 2022)
  • K182784 — MUTYH-Associated Polyposis (MAP) (January 18, 2019)
  • DEN180028 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (October 31, 2018)
  • DEN170046 — 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (March 6, 2018)
  • DEN160026 — 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Th (April 6, 2017)
  • DEN140044 — 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) (February 19, 2015)

Other clearances for product code QDJ

  • K221885 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (October 26, 2022)
  • DEN180028 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (October 31, 2018)