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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 CP PSA ASSAY
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP950021
Supplement NumberS007
Date Received07/22/2005
Decision Date10/07/2005
Product Code MTF 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TRANSFER OF THE ASSAY TO A NEW BAYER PLATFORM, THE ADVIA CENTAUR CP SYSTEM. THE ADVIA CENTAUR CP PSA ASSAY IS INTENDED TO QUANTITATIVELY MEASURE PROSTATE-SPECIFIC-ANTIGEN (PSA) IN HUMAN SERUM USING THE ADVIA CENTAUR CP SYSTEM.
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