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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceABBOTT IMX FREE PSA
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
AP5N-2 DEPT 09VB
ABBOTT PARK, IL 60064-6070
PMA NumberP980007
Supplement NumberS003
Date Received01/31/2003
Decision Date02/05/2004
Product Code MTG 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE ABBOTT ARCHITECT FREE PSA REAGENTS TO BE USED WITH THE IMX FREE PSA AND IS INDICATED FOR: THE IMX FREE PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THE IMX FREE PSA ASSAY IS INTENDED TO BE USED IN CONJUNCTION WITH THE IMX TOTAL PSA ASSAY IN MEN AGED 50 YEARS OR OLDER WITH TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND NON-SUSPICIOUS DRE TO DETERMINE THE % FREE PSA VALUE. THE IMX % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE.
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