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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.
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
bioMerieux, Inc.
595 anglum rd.
hazelwood, MO 63042
PMA NumberP040008
Date Received02/17/2004
Decision Date07/08/2004
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 04M-0342
Notice Date 08/04/2004
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the vidas tpsa assay indicated as follows: vidas tpsa is intended for use with a vidas (vitek immunodiagnostic assay system) instrument as an automated enzyme-linked fluorescent immunoassay (elfa) for the quantitative measurement of total 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 (dre) in men age 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S011 
S012 S013