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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.
 
DeviceAtellica IM Hepatitis B e Antigen (HBeAg)
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSiemens Healthcare Diagnostics
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP090024
Supplement NumberS012
Date Received07/22/2024
Decision Date01/13/2025
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 ADVIA Centaur HBeAg assay (P090024), from the ADVIA Centaur XP to the Atellica CI analyzer, which will be known as the Atellica IM HBeAg assay.
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