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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 AXSYM TOTAL PSA ASSAY
Generic NameANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Regulation Number862.2160
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3500
PMA NumberP910007
Supplement NumberS011
Date Received07/29/2004
Decision Date09/27/2004
Product Code JJE 
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 OF THE FOLLOWING MODIFICATIONS TO THE ABBOTT AXSYM TOTAL PSA ASSAY: 1) CHANGE THE FUNCTIONAL SENSITIVITY CLAIM TO 0.06 NG/ML 2) ADDITION OF FLOMAX TO THE ANALYTICAL SPECIFICITY SECTION OF THE PACKAGE INSERT 3) MINOR LABELING CHANGES TO THE PACKAGE INSERT FOR THE PURPOSE OF CLARIFICATION, UPDATES AND CONFORMATION TO REQUIREMENTS OF THE EUROPEAN COMMUNITY DIRECTIVES. THE AXSYM TOTAL PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPSIN) IN HUMAN SERUM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
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