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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 core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
511 Benedict Avenue
Tarrytown, NY 10591
PMA NumberP090024
Supplement NumberS004
Date Received12/22/2017
Decision Date07/12/2018
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for migration of the ADVIA Centaur Hepatitis B e Antigen and the ADVIA Centaur Hepatitis B e Antigen Quality Control onto the Atellica IM analyzer. The device, as modified, will be marketed under the trade name Atellica IM Hepatitis B e Antigen (HBeAg) and Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC) and is indicated for: Atellica IM Hepatitis Be Antigen (HBeAg)The Atellica IM Hepatitis Be Antigen (HBeAg) assay is an in vitro diagnostic immunoassay for use in the qualitative determination of the hepatitis B e antigen (HBeAg) in human serum and plasma (potassium EDTA, lithium heparin, and sodium heparin) from individuals who have signs and symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the Atellica™ IM Analyzer. This assay, in conjunction with other serological and clinical information, is intended only for the determination of chronic infection with hepatitis B virus. Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC)The Atellica® IM Hepatitis B e Antigen Quality Control (HBeAg QC) is for use in monitoring theperformance of the Atellica IM HBeAg assay using the Atellica® IM Analyzer.The performance of the Atellica IM HBeAg quality control material has not been establishedwith any other HBeAg assay.
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