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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.
 
DeviceHBSAG
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSiemens Healthcare Diagnostics Products, Ltd.
Glyn Rhonwy
Llanberis LL55 4EL
PMA NumberP010050
Supplement NumberS012
Date Received02/18/2011
Decision Date05/12/2011
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL, THE IMMULITE 2000 XPI ANALYZER, AS A NEW FAMILY MEMBER OF THE CURRENTLY APPROVED IMMULITE 2000 ANALYZER, TO BE USED WITH THE CURRENTLY APPROVED IMMULITE 2000 HBSAG ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2000 HBSAG ASSAY AN IS INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS B VIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.
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