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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 Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
PMA NumberP080008
Supplement NumberS002
Date Received10/22/2012
Decision Date01/18/2013
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the packaging insert by defining the phrase "instrument of the vidas family" as "instrument of the vidas family: vidas or minividas" and replacing "instruments of the vidas family" with "vidas instruments" in the intended use. The device, vidas® total psa, is intended for use with the vidas instruments (vitek® immunodiagnostic assay system) as an automated enzyme-linked fluorescent immunoassay (elfa) for the quantitative measurement oftotal prostate specific antigen in human serum. The vidas tpsa assay is indicated as an aid in the management of patients with prostate cancer and as an aid in the detection of prostate cancer in conjunction with digital rectal examination (ore) in men age 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer. The device, vidas® free psa 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 elf a technique (enzyme linked fluorescent assay). The vidas free psa 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 (ore) 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 % free psa value can be used as an aid in discriminating between prostate cancer and benign disease. Prostate biopsy is required for diagnosis of prostate cancer.