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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.
 
DeviceBAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS
Generic NameANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP990055
Supplement NumberS001
Date Received03/27/2001
Decision Date12/07/2001
Product Code NAF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE ASSAY TO THE BAYER ACS:180 AND ADVIA CENTAUR ANALYZERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BAYER ACS:180 OR ADVIA CENTAUR COMPLEXED PSA ASSAY AND ARE INDICATED AS FOLLOWS: THIS IN VITRO DEVICE IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM USING THE BAYER DIAGNOSTICS IMMUNO 1, THE ACS:180 SYSTEM, OR THE ADVIA CENTAUR SYSTEM. THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER.
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