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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 NumberS005
Date Received04/22/2026
Decision Date05/20/2026
Product Code QZH 
Advisory Committee Toxicology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230032.
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