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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.
 
DeviceELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP000027
Supplement NumberS001
Date Received11/07/2001
Decision Date04/29/2002
Product Code LTJ 
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 ELECSYS FREE PSA ASSAY TO THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS FREE PSA IMMUNOASSAY, ELECSYS FREE PSA CALSET AND ELECSYS FREE PSA CALCHECK AND ARE INDICATED AS FOLLOWS: IMMUNOASSAY FOR THE IN VITRO QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN IN HUMAN SERUM AND PLASMA. THE ELECSYS FREE PSA IMMUNOASSAY IS INDICATED FOR MEASUREMENT OF FPSA IN CONJUNCTION WITH THE ELECSYS TOTAL PSA TO DEVELOP A RATIO (% FPSA) OF FPSA TO TPSA. THIS RATIO IS USEFUL WHEN USED IN CONJUNCTION WITH THE ELECSYS TOTAL PSA TEST AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATE CONDITIONS IN MEN AGE 50 YEARS OR OLDER WHO HAVE A DIGITAL RECTAL EXAMINATION (DRE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND AN ELECSYS TOTAL PSA VALUE IN THE RANGE 4-10NG/ML. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS. ELECSYS FREE PSA CALSET IS USED FOR CALIBRATING THE QUANTITATIVE ELECSYS FREE PSA ASSAY ON THE ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY SYSTEMS. FREE PSA CALCHECK IS FOR USE IN THE VERIFICATION OF THE CALIBRATION ESTABLISHED BY THE ELECSYS FREE PSA REAGENT ON ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS.
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