DevicePMAs@therightstef:P920030_S002 JSONTXT 13 Projects

Approval for the addition of a new indication for use. The device, as modified, will be marketed under the trade names ACS: 180 PSA2 assay and ACS: Centaur PSA2 assay and is indicated for the following indications for use: as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. Prostatic biopsy is required for the diagnosis of cancer; and as aid in the management of patients with prostate cancer.