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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 Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameantigen(complexed),prostate specific,(cpsa)
333 coney street
walpole, MA 02032-1516
PMA NumberP990055
Date Received10/01/1999
Decision Date09/08/2000
Product Code
NAF[ Registered Establishments with NAF ]
Docket Number 00M-1524
Notice Date 09/26/2000
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the bayer immuno 1(tm) complexed psa assay. The in vitro device is intended to quantitatively measure complexed prostate-specific antigen (cpsa) in human serum on the bayer immuno 1(tm) system. This device is indicated for the measurement of serum complexed psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Biopsy of the prostate is required for the diagnosis of prostate cancer. This device is further indicated as an aid in the management (monitoring) of prostate cancer patients. This diagnostic method is not intended for use on any other system.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015