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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 NameABBOTT IMX FREE PSA
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Generic Namefree psa
ApplicantABBOTT LABORATORIES
PMA NumberP980007
Supplement NumberS003
Date Received01/31/2003
Decision Date02/05/2004
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 modification of the abbott architect free psa reagents to be used with the imx free psa and is indicated for: the imx free psa assay is a microparticle enzyme immunoassay (meia) for the quantitative measurement of free prostate specific antigen (psa) in human serum. The imx free psa assay is intended to be used in conjunction with the imx total psa assay in men aged 50 years or older with total psa values between 4 and 10 ng/ml and non-suspicious dre to determine the % free psa value. The imx % free psa value can be used as an aid in discriminating between prostate cancer and benign disease.
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