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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantBAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN, NY 10591
PMA NumberP040018
Date Received04/01/2004
Decision Date12/22/2004
Reclassified Date 02/09/2006
Product Code LOL 
Docket Number 05M-0129
Notice Date 04/12/2005
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ADVIA CENTAUR HAV IGM. HAV IGM READYPACK REAGENTS: THIS DEVICE IS INDICATED FOR USE FOR THE ADVIA CENTAUR HAV IGM ASSAY AND IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IGM RESPONSE TO THE HEPATITIS A VIRUS (HAV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT INFECTION (USUALLY 6 MONTHS OR LESS) WITH HEPATITIS A VIRUS. HAV IGM QUALITY CONTROL MATERIALS: THE CONTROLS ARE INDICATED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HAV IGM ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HAV IGM QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HAV IGM ASSAYS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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