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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 TOTAL PSA ASSAY
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3500
PMA NumberP910007
Supplement NumberS010
Date Received04/01/2004
Decision Date04/28/2004
Product Codes JIS JJX MTF 
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 THE ABBOTT ARCHITECT TOTAL PSA ASSAY TO BE USED ON THE ARCHITECT I2000SR PLATFORM, A MEMBER OF THE ARCHITECT I2000 INSTRUMENT FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME ARCHITECT TOTAL PSA ASSAY AND IS INDICATED: THE ARCHITECT TOTAL PSA ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPSIN [PSA-ACT]) 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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