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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.
 
DeviceACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantBECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD M/S
W-110
BREA, CA 92822
PMA NumberP970038
Supplement NumberS005
Date Received08/19/2002
Decision Date11/27/2002
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 THE ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER. THE DEVICE IS INDICATED FOR: THE ACCESS HYBRITECH FREE PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS. ACCESS HYBRITECH FREE PSA IS INTENDED TO BE USED WITH HYBRITECH (TOTAL) PSA TO CALCULATE THE RATIO OF FREE PSA TO TOTAL PSA EXPRESSED AS A PERCENTAGE (PERCENT FREE PSA). PERCENT FREE PSA AS MEASURED BY THE HYBRITECH ASSAYS IS INDICATED FOR USE AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIONS, WHEN USED IN CONJUNCTION WITH HYBRITECH (TOTAL) PSA FOR PROSTATE CANCER DETECTION IN MEN AGED 50 YEARS AND OLDER WITH TOTAL PSA BETWEEN 4 AND 10 NG/ML WITH DIGITAL RECTAL EXAMINATION FINDINGS THAT ARE NOT SUSPICIOUS FOR CANCER. PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.
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