QDJ · Class II · 21 CFR 862.3364

FDA Product Code QDJ: Direct-to-consumer Access Pharmacogenetic Assessment System

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.

Leading manufacturers include 23AndMe, Inc..

3
Total
2
Cleared
170d
Avg days
2018
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Direct-to-consumer Access Pharmacogenetic Assessment System Devices (Product Code QDJ)

3 devices
1–3 of 3
Cleared Oct 26, 2022
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
K221885
23AndMe, Inc.
Chemistry · 119d

About Product Code QDJ - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QDJ since 2018, with 2 receiving FDA clearance (average review time: 170 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QDJ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →