|Trade Name||DIMENSION TPSA FLEX REAGENT CARTRIDGE|
|Classification Name||prostate-specific antigen (psa) for management of prostate cancers|
|Applicant||DADE BEHRING, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for design changes. The design changes include modification of the assay response to provide equivalent results for samples with varying mixtures of free psa and psa-act and optimization of the method design to minimize method response to human anti-murine immunoglobulin antibodies and human anti-bovine immunoglobulin antibodies. The device, as modified, will be marketed under the trade name dimension tpsa flex reagent cartridge 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.