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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Namekit, test, free prostate specific antigen (free psa)
ApplicantBECKMAN COULTER, INC.
PMA NumberP970038
Supplement NumberS005
Date Received08/19/2002
Decision Date11/27/2002
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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