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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 TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP990056
Date Received10/04/1999
Decision Date11/22/2000
Product Code MTF 
Docket Number 00M-1660
Notice Date 12/12/2000
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ELECSYS(R) TOTAL PSA IMMUNOASSAY AND ELECSYS(R) TOTAL PSA CALSET. THE DEVICE, A QUANTITATIVE IN VITRO DIAGNOSTIC TEST FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) IN HUMAN SERUM AND PLASMA IS INDICATED FOR THE MEASUREMENT OF TOTAL PSA IN CONJUNCTION WITH DOGOTA; RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE TEST ID FURTHER INDICATED FOR SERIAL MEASUREMENT OF TPSA TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS. THE ELECTOCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS(R) 1010 AND 2010 IMMUNOASSAY ANALYZERS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 
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