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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.
 
DeviceACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSiemens Healthcare Diagnostics
333 Coney St.
East Walpole, MA 02032
PMA NumberP950021
Supplement NumberS002
Date Received07/31/2000
Decision Date12/22/2000
Product Code LTJ 
Docket Number 01M-0038
Notice Date 02/07/2001
Advisory Committee Immunology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ACS:180 AND ADVIA CENTAUR IMMUNOASSAY ANALYZERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ACS:180 PSA IMMUNOASSAY AND ADVIA CENTAUR PSA IMMUNOASSAY AND IS INDICATED FOR THE FOLLOWING: THE BAYER ACS:180(TM) AND ADVIA CENTAUR(TM) PSA ASSAYS ARE IN VITRO DEVICES INTENDED FORO THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THESE DEVICES ARE INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THESE DEVICES ARE FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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