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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
PMA NumberP000021
Supplement NumberS013
Date Received12/02/2008
Decision Date05/19/2010
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
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 5) usage on the dimension vista 1500 system connected to the streamlab analytical workcell laboratory automation system 6) the new dimension vista psa calibrator for use with the dimension vista tpsa and fpsa methods. The device, as modified, will be marketed under the trade name dimension vista tpsa flex reagent cartridge and is indicated for the following uses: the tpsa method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (psa) in human serum and plasma on the dimension vista system: 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. The dimension vista psa calibrator will be marketed separately for use with the dimension vista tpsa flex reagent and is indicated for the calibration of total (tpsa) and free (fpsa) prostate specific antigen methods on the dimension vista systems.