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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 NumberS002
Date Received05/17/2024
Decision Date11/07/2024
Product Code QZH 
Advisory Committee Toxicology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the INFINITI High-Throughput System (HTS) for use in analyzing samples with the AvertD test
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