|Trade Name||DIMENSION TPSA FLEX REAGENT CARTRIDGE|
|Classification Name||prostate-specific antigen (psa) for management of prostate cancers|
|Applicant||DADE BEHRING, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of the dimension tpsa flex reagent cartridge on the dimension rxl max analyzer. The device will be marketed under the same trade name and is indicated for: the tpsa method for the dimension clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure total prostate specific antigen (psa) in human serum and plasma: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) as an aid in the management (monitoring) of prostate cancer patients.