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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAvertD and AvertD Buccal Sample Collection Kit
Generic NameOpioid use disorder genetic risk variant detection system and collection kit
ApplicantAutoGenomics, Inc.
1600 Faraday Avenue
Carlsbad, CA 92008
PMA NumberP230032
Date Received09/25/2023
Decision Date12/19/2023
Product Code QZH 
Docket Number 23M-5501
Notice Date 12/19/2023
Advisory Committee Toxicology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
AvertD™ is a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA isolated from buccal samples collected from individuals 18 years of age and older. The test may be used as part of a clinical evaluation and risk assessment to identify patients who may be at elevated risk for developing opioid use disorder (OUD). The test is indicated for use only in patients prior to receiving a first prescription of oral opioids for 4-30 days for acute pain, such as in patients scheduled to undergo a planned surgical procedure and who consent to having the test performed. The AvertD™ Buccal Sample Collection Kit is intended for use in the non-invasive collection, transport and storage of buccal specimens. DNA from the buccal sample will be suitable for use in AvertD. Buccal samples are collected by a qualified healthcare professional. For use only in individuals 18 years or older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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