DevicePMAs@therightstef:P850048_S017 JSONTXT 13 Projects

Approval for the access hybritech psa on the access 2 immunoassay analyzer. The device is indicated for: the access hybritech psa assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (psa) in human serum using the access immunoassy systems. The device is indicated for the measurement of serum psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for diagnosis of cancer. The device is further indicated for the serial measurement of psa to aid in the prognosis and management of patients with prostate cancer.