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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.
 
DeviceADVIA CENTAUR ANTI-HBS (AHBS)
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP030029
Supplement NumberS009
Date Received09/28/2009
Decision Date09/01/2010
Withdrawal Date05/24/2016
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 ADDING QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA TO THE INTENDED USE.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA® CENTAUR ANTI-HBS(AHBS) ASSAY ON CENTAUR CP AND IS INDICATED FOR:ADVIA® CENTAUR ANTI-HBS (AHBS) ASSAY ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACEANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THEDETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TOOR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAYBE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASEASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.
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