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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 Anti-HBe2 (aHBe2)
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSiemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown, NY 10591
PMA NumberP200017
Supplement NumberS003
Date Received09/26/2024
Decision Date03/20/2025
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 Siemens ADVIA Centaur aHBe2 assay (P200017) from the ADVIA Centaur XP to Atellica CI system (referred to as Atellica CI analyzer), which will be known as Atellica IM aHBe2 assay
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