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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.
 
DeviceAlinity i HBsAg Next Qualitative assay, Alinity i HBsAg Next Confirmatory assay
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantAbbott Laboratories
100 Abbott Park Rd., Dept: 09aa, Bldg: Ap8-1
Abbott Park, IL 60064
PMA NumberP210003
Supplement NumberS006
Date Received04/03/2023
Decision Date09/28/2023
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
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 Migration of the Abbott ARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory assay (P210003) to the Alinity i system (referred to as the Alinity i analyzer), which will be known as the Alinity i HBsAg Next Qualitative and Alinity i HBsAg Next Confirmatory assay.
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