Approval of the acs: 180 and the centaur complexed psa (cpsa) assays on the advia centaur cp system.  The device, as modified, will be marketed under the trade name advia centaur cp cpsa and is indicated:  the in vitro diagnostic assay is intended to quantitatively measure complexed prostate-specific antigen (cpsa) in human serum using the advia centaur system.  The assay 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.  The assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.