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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 NameADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)
Classification Nameantigen(complexed),prostate specific,(cpsa)
Generic Nameimmunoassay for the quantitative measurement of complexed prostate-specific antigen (cpsa) in human serum
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
PMA NumberP990055
Supplement NumberS012
Date Received04/10/2009
Decision Date06/10/2009
Product Code
NAF
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the advia centaur xp instrument (with version 5. 0 software) to the instrument(s) using the advia centaur cpsa assay. The device, as modified, will be marketed under the trade name advia centaur and advia centaur xp cpsa assay and 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 and older. Prostate biopsy is required for the diagnosis of prostate cancer. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer.
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