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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-HBS2 MASTER CURVE MATERIALS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
511 BENEDICT AVE.
TARRYTOWN, NY 10591
PMA NumberP100039
Supplement NumberS002
Date Received09/28/2012
Decision Date09/26/2013
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE AD VIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVEMATERIAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AD VIA CENTAUR ANTIHBS2(AHBS2) ASSAY, ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL, ANDADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL AND IS INDICATED FOR:ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY: THE ADVIA CENTAUR ANTI-HBS2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEAND QUANTITATIVE DETENNINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA (EDTA, LITHIUM-HEPARINIZED, OR SODIUM-HEPARINIZED)AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAYRESULTS MAY BE USED AS AN AID IN THE DETENNINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW ADIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.THIS ASSAY HAS NOT BEEN FDA-CLEARED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS. ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL: FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS2 ASSAY ON THE ADVIACENTAUR SYSTEMS. THE PERFORMANCE OF THE ANTI-HBS2 QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.ADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL: THE ADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL (MCM) IS FOR IN VITRO USE IN THE VERIFICATION OF CALIBRATION AND REPORTABLE RANGE OF THE AD VIA CENTAUR AHBS2 ASSAY.
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