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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.
 
DeviceCOMPLEXED PSA MICROTITER ELISA
Generic NameANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP990055
Supplement NumberS002
Date Received09/20/2001
Decision Date03/19/2002
Product Code NAF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD A MICROTITER PLATE CAPTURE SYSTEM TO THE CURRENT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONCOGENE SCIENCE COMPLEXED PSA MICROTITER ELISA AND IS INDICATED FOR THE FOLLOWING: THE ONCOGENE SCIENCE COMPLEXED PSA MICROTITER ELISA IS AN IN VITRO DIAGNOSTIC ASSAY INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PSA (CPSA) IN HUMAN SERUM. THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM CPSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ONCOGENE SCIENCE COMPLEXED PSA MICROTITER ELISA IS FURTHER INDICATED FOR FOLLOW-UP AND MONITORING OF PATIENTS WITH PROSTATE CANCER. CPSA LEVELS MEASURED BY THIS DEVICE SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL AND OTHER DIAGNOSTIC PROCEDURES IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
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