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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 NameBAYER ADVIA IMS PSA ASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameprostate specific antigen assay (psa)
ApplicantBAYER HEALTHCARE, LLC
PMA NumberP950021
Supplement NumberS006
Date Received07/17/2003
Decision Date09/02/2003
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the immuno 1 prostate specific antigen (psa) on the advia integrated modular system (ims). The device, as modified, will be marketed under the trade name advia ims prostate specific antigen (psa) and is indicated for: the advia ims prostate specific antigen (psa) method is for in vitro diagnostic use to quantitatively measure prostate specific antigen (psa) in human serum. This assay is indicated for the measurement of the serum psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 year and older. This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients. This diagnostic method is not intended for use on any other system.
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