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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 AXSYM TOTAL PSA
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameabbolabo
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Supplement NumberS005
Date Received09/25/1997
Decision Date02/02/2004
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the abbott axsym total psa assay. The axsy total psa is a microparticle enzyme immunoassay (meia) for the quantitative determination of total psa (both free psa and psa complexed to alpha-1 antichymotrypsin) in human serum: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients.
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