bioMerieux VIDAS total PSA assay - P040008
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Vidas TPSA assay
Applicant: bioMerieux Inc.
Address: 595 Anglum Drive Hazelwood, MO 63042-2320
Approval Date: July 8, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040008a.pdf
What is it? The Vidas TPSA assay is an in vitro diagnostic test that measures total prostate-specific antigen (TPSA) in a blood sample. PSA is an enzyme produced by cells of the prostate gland. Healthy men have low concentrations of PSA in their blood. This test, when used with digital rectal exam (DRE), an exam of the size and texture of the prostate, is useful in the detection of prostate cancer in men aged 50 years and older. Several in vitro diagnostic assays for total PSA are available.
How does it work? The Vidas TPSA assay is used by a professional clinical laboratory to test a patient’s blood sample for elevated amounts of PSA. A PSA level above 4.0 ng/mL indicates an elevated blood test, and the possibility of prostate cancer. A surgical removal of tissue (prostate biopsy) is required to confirm the diagnosis of prostate cancer.
When is it used? A doctor uses a TPSA test to help diagnose prostate cancer. A doctor will order this test for a patient who:
- is a male 50 years or older, and
- has a prostate gland that appears of normal size and texture during a digital rectal exam (DRE).
What will it accomplish? The Vidas TPSA assay aids the physician in the detection of prostate cancer. Confirmation of prostate cancer is determined by prostate biopsy.
Seven hundred (700) serum samples from 34 sites in the U.S. were studied from men aged fifty (50) years or older without a history of benign prostate disease or a history of prostate cancer evaluation referred to a urologist for evaluation of the presence of prostate cancer, including a prostate biopsy. The study showed that the combination of PSA with DRE detected significantly more cancer cases than DRE alone.
When should it not be used? There are no known contraindications for this device.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040008