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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.
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Namefree psa
PMA NumberP980007
Supplement NumberS005
Date Received08/05/2004
Decision Date09/10/2004
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of flomax to the analytical specificity section of the package insert and minor labeling changes to the abbott axsym free psa assay for the purpose of clarification, updates and conformation to requirements of the european community directives. The device, as modified, will be marketed under the same trade name axsym free psa assay and is indicated as follows: the axsym free psa assay is a microparticle enzyme immunoassay (meia) for the quantitative measurement of free prostate specific antigen (psa) in human serum. The axsym free psa assay is intended to be used in psa values between 4 and 10 ng/ml and non-suspicious dre to determine the % free psa value. The axsym % free psa value can be used as an aid in discriminating between prostate cancer and benign disease.