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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 HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP030040
Supplement NumberS004
Date Received03/09/2009
Decision Date04/09/2009
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THE APPROVED DEVICE ADVIA CENTAUR HBC IGM ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETEDUNDER THE TRADE NAME ADVIA CENTAUR HBC IGM ASSAY AND IS INDICATED FOR:THE ADVIA CENTAUR HBC IGM ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION OF IGM RESPONSE TO HEPATITIS B VIRUS CORE ANTIGEN IN HUMAN SERUM ANDPLASMA (EDTA OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIACENTAUR XP SYSTEMS. THE ASSAY USES RECOMBINANT HBC ANTIGEN. THIS ASSAY MAY BE USED IN COMBINATION WITH OTHER HEPATITIS B VIRUS (HBV) MARKER ASSAYS TO DEFINE THE CLINICAL STATUS OF KNOWN HBV INFECTED PATIENTS OR CAN BE COMBINED WITH OTHER HBV. HAV (HEPATITIS AVIRUS), AND HCV (HEPATITIS C VIRUS) ASSAYS FOR THE DIAGNOSIS OF PATIENTS PRESENTING SYMPTOMS OF ACUTE VIRAL HEPATITIS.ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR IMMUNOCOMPRO-MISED ORIMMUNOSUPPRESSED PATIENTS, CORD BLOOD, NEONATAL SPECIMENS, INFANTS, OR CHILDREN.ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HBC IGM ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HBV SEROLOGICAL MARKERS.
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