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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
9115 hague rd.
indianapolis, IN 46250
PMA NumberP990056
Date Received10/04/1999
Decision Date11/22/2000
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 00M-1660
Notice Date 12/12/2000
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S019 S020 
S021 S022 S023 S025