Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVIDAS TOTAL PSA
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantbioMerieux, Inc.
595 Anglum Rd.
Hazelwood, MO 63042
PMA NumberP040008
Supplement NumberS003
Date Received10/11/2012
Decision Date01/18/2013
Withdrawal Date 10/11/2017
Product Code MTF 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 THE INTENDED USE. THE DEVICE, VIDAS® TOTAL PSA, IS INTENDED FOR USE WITH THE VIDAS INSTRUMENTS (VITEK® IMMUNODIAGNOSTIC ASSAY SYSTEM) AS AN AUTOMATED ENZYME-LINKED FLUORESCENT IMMUNOASSAY (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.
-
-