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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 ADVIA IMS COMPLEXED PSA ASSAY
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameantigen(complexed),prostate specific,(cpsa)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
333 coney street
walpole, MA 02032-1516
PMA NumberP990055
Supplement NumberS008
Date Received07/22/2005
Decision Date10/07/2005
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE ACS:180 AND THE CENTAUR COMPLEXED PSA (CPSA) ASSAYS ON THE ADVIA CENTAUR CP SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR CP CPSA AND IS INDICATED: THE IN VITRO DIAGNOSTIC ASSAY IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM USING THE ADVIA CENTAUR SYSTEM. THE ASSAY 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. BIOPSY OF THE PROSTATE IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
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