- Device
- VIDAS FREE PSA RT
- Applicant
- bioMerieux, Inc.
- PMA number
- P080008
- Supplement
- S002
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2013-01-18
- Decision code
- APPR
- Date received
- 2012-10-11
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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 THEINTENDED USE. THE DEVICE, VIDAS® TOTAL PSA, IS INTENDED FOR USE WITH THE VIDAS INSTRUMENTS(VITEK® IMMUNODIAGNOSTIC ASSAY SYSTEM) AS AN AUTOMATED ENZYME-LINKED FLUORESCENTIMMUNOASSAY (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.