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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 TOTAL PSA
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 NumberS013
Date Received05/05/2005
Decision Date06/13/2005
Product Code JJE 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE NEW METHOD COMPARISONS BETWEEN THE IMX TOTAL PSA ASSAY AND THE IMX PSA ASSAY. THE COMPARISONS INCLUDE REGRESSION ANALYSES (PASSING-BABLOK AND LEAST SQUARES LINEAR REGRESSION) AND BIAS ANALYSIS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME IMX TOTAL PSA ASSAY AND IS INDICATED AS FOLLOWS: THE IMX 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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