|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS|
|Classification Name||antigen(complexed),prostate specific,(cpsa)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of the assay to the bayer acs:180 and advia centaur analyzers. The device, as modified, will be marketed under the trade names bayer acs:180 or advia centaur complexed psa assay and are indicated as follows: this in vitro device is intended to quantitatively measure complexed prostate-specific antigen (cpsa) in human serum using the bayer diagnostics immuno 1, the acs:180 system, or the advia centaur 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.