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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received03/09/1998
Decision Date02/05/2004
Product Code
MTG[ Registered Establishments with MTG ]
Docket Number 04M-0253
Notice Date 06/05/2004
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the axsym free psa assay. The device 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.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033