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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantBAYER HEALTHCARE, DIAGNOSTICS DIVISION
511 BENEDICT AVE.
TARRYTOWN, NY 10591
PMA NumberP040017
Date Received04/01/2004
Decision Date03/07/2005
Reclassified Date 02/09/2006
Product Code LOL 
Docket Number 05M-0110
Notice Date 03/21/2005
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADVIA CENTAUR HAV TOTAL ASSAY AND QUALITY CONTROL MATERIALS. HAV TOTAL ASSAY INDICATION FOR USE: THE ADVIA CENTAUR HAV TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS A VIRUS (ANTI-HAV ) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THIS ANTI-HAV ASSAY IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION. HAV TOTAL QUALITY CONTROL MATERIALS INDICATION FOR USE: FOR MONITORING THE PERFORMANCE OF THE HAV TOTAL ASSAY ON ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HAV TOTAL QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HAV TOTAL ASSAY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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