DevicePMAs@therightstef:P990055_S012 JSONTXT 11 Projects

Approval for the addition of the advia centaur xp instrument (with version 5.0software) 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 isindicated 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.