DevicePMAs@therightstef:P990056_S000 JSONTXT 11 Projects

Approval for the elecsys(r) total psa immunoassay and elecsys(r) total psa calset. The device, a quantitative in vitro diagnostic test for total prostate-specific antigen (tpsa) in human serum and plasma is indicated for the measurement of total psa in conjunction with dogota; rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of prostate cancer. The test id further indicated for serial measurement of tpsa to aid in the management of prostate cancer patients. The electochemiluminescence immunoassay "eclia" is intended for use on the roche elecsys(r) 1010 and 2010 immunoassay analyzers.