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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceELECSYS FREE PSA IMMUNOASSAY/CALSET/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
Date Received07/07/2000
Decision Date12/12/2000
Product Code LTJ 
Docket Number 00M-1683
Notice Date 01/03/2001
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ELECSYS(R) FREE PSA IMMUNOASSAY FOR ELECSYS 1010 AND 2010 IMMUNOASSAY ANALYZERS. THE DEVICE IS INDICATED 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 ASSAY 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 PROSTATIC CONDITIOND IN MEN AGE 50 YEARS OR OLDER WHO HAVE A DIGITAL RECTOAL EXAMINATION (DRE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND AN ELECSYS TOTAL PSA VALUE IN THE RANGE 4 NG/ML TO 10 NG/ML. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ELECTROCHEMILUMINESCENE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 1010 AND 2010 IMMUNOASSAY ANALYZERS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 
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