VIDAS FREE PSA RT ASSAY
FDA premarket approval P080008 · decided 2009-10-08
Approval details
- PMA number
- P080008
- Trade name
- VIDAS FREE PSA RT ASSAY
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- bioMerieux, Inc.
- Date received
- 2008-03-21
- Decision date
- 2009-10-08
- Days to decision
- 566 days
- Decision code
- APWD
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR THE VIDASFREE PSA RT ASSAY. THE VIDAS FPSA RT IS AN AUTOMATED QUANTITATIVETEST FOR USE ON THE VIDAS INSTRUMENTS, FOR THE QUANTITATIVE MEASUREMENT OF THE FREE FRACTION OFPROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ELFA TECHNIQUE (ENZYME LINKEDFLUORESCENT ASSAY). THE VIDAS FPSA RT IS INTENDED TO BE USED IN CONJUNCTION WITH THE VIDASTPSA ASSAY IN MEN AGE 50 YEARS OR OLDER WHO HAVE DIGITAL RECTAL EXAMINATION (DRE) THAT IS NOTSUSPICIOUS FOR PROSTATE CANCER AND VIDAS TPSA VAL
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