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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVIDAS FREE PSA RT ASSAY
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantBIOMERIEUX, INC.
PMA NumberP080008
Date Received03/21/2008
Decision Date10/08/2009
Product Code
MTG[ Registered Establishments with MTG ]
Docket Number 09M-0536
Notice Date 11/05/2009
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the vidas free psa rt assay. The vidas fpsa rt is an automated quantitative test for use on the vidas instruments, for the quantitative measurement of the free fraction of prostate specific antigen (psa) in human serum using the elfa technique (enzyme linked fluorescent assay). The vidas fpsa rt is intended to be used in conjunction with the vidas tpsa assay in men age 50 years or older who have digital rectal examination (dre) that is not suspicious for prostate cancer and vidas tpsa values between 4 and 10 ng/ml to determine the %free psa value. The vidas %fpsa value can be used as an aid in discriminating between prostate cancer and benign disease. Prostate biopsy is required for diagnosis of prostate cancer.
Approval Order Approval Order
Supplements: S001 S002 
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