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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 ARCHITECT 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 NumberS004
Date Received04/01/2004
Decision Date05/07/2004
Product Code MTG 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITION OF THE ARCHITECT FREE PSA TO THE I2000SR PLATFORM, A MEMBER OF THE ARCHITECT I2000 INSTRUMENT FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT FREE PSA AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THE ARCHITECT FREE PSA IS INTENDED TO BE USED IN CONJUNCTION WITH THE ARCHITECT TOTAL PSA ASSAY IN MEN AGED 50 YEARS OR OLDER WITH TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DRE NON-SUSPICIOUS FOR CANCER TO DETERMINE THE % FREE PSA VALUE. THE ARCHITECT % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE.
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