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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 COMPLEXED PSA ASSAY
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameimmunoassay for the quantitative measurement of complexed prostate-specific antigen (cpsa) in human serum
ApplicantBAYER HEALTHCARE, LLC
PMA NumberP990055
Supplement NumberS008
Date Received07/28/2005
Decision Date10/07/2005
Product Code
NAF[ Registered Establishments with NAF ]
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 of the acs:180 and the centaur complexed psa (cpsa) assays on the advia centaur cp system. The device, as modified, will be marketed under the trade name advia centaur cp cpsa and is indicated: the in vitro diagnostic assay is intended to quantitatively measure complexed prostate-specific antigen (cpsa) in human serum using the advia centaur system. The assay is indicated for the measurement of serum complexed psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Biopsy of the prostate is required for the diagnosis of prostate cancer. The assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.
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