| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | VIDAS FREE PSA RT ASSAY |
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| Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
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| Applicant | bioMerieux, Inc.
595 Anglum Rd.
Hazelwood, MO 63042 |
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| PMA Number | P080008 |
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| Date Received | 03/21/2008 |
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| Decision Date | 10/08/2009 |
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Withdrawal Date
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01/31/2014 |
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| Product Code |
MTG |
| Docket Number | 09M-0536 |
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| Notice Date | 11/05/2009 |
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| Advisory Committee |
Immunology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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 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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 |
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