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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAvertD and AvertD Buccal Sample Collection Kit
Generic NameOpioid use disorder genetic risk variant detection system and collection kit
ApplicantAutoGenomics, Inc.
1600 Faraday Ave.
Carlsbad, CA 92008
PMA NumberP230032
Supplement NumberS004
Date Received01/09/2026
Decision Date04/10/2026
Product Code QZH 
Advisory Committee Toxicology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of venous whole blood as sample type for use with the AvertD test.
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