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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 Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
9115 hague rd.
indianapolis, IN 46250
PMA NumberP000027
Date Received07/07/2000
Decision Date12/12/2000
Product Code
LTJ[ Registered Establishments with LTJ ]
Docket Number 00M-1683
Notice Date 01/03/2001
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S017 S018 S019 S020 
S021 S022 S024