|Trade Name||FPSA FLEX REAGENT CARTRIDGE|
|Classification Name||test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions|
|Generic Name||prostate specific antigen (psa) for detection and management of prostate cancers|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes: 1) detection technology from spectrophotometry to chemiluminesence; 2) appropriate reagent process changes to accommodate chemiluminesence detection; 3) usage on the dimension vista 1500 system; 4) usage on the dimension vista 3000t system which consists of two dimension vista 1500 systems connected by a sample track transport mechanism; and 5) usage on the dimension vista 1500 system connected to the streamlab analytical workcell laboratory automation system. The device, as modified, will be marketed under the trade name dimension vista fpsa flex reagent cartridge and is indicated for: the fpsa method for the dimension vista system is an in vitro diagnostic test intended to quantitatively measure free prostate specific antigen (fpsa) in human serum and plasma. Measurements of fpsa are used in conjunction with total psa (tpsa) method on dimension vista systen to calculate fpsa to tpsa ratio expressed as a percent fpsa. The percent fpsa is used as an aid in distinguishing prostate cancer from benign prostate conditions in men 50 years or older with tpsa of 4. 0 to 1. 0 ng/ml and dre findings not suspicious for cancer. Prostate biopsy is required for diagnosis of cancer.