DevicePMAs@therightstef:P140021_S005 JSONTXT 11 Projects

Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the Modular ANALYTICS E170 analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV and is indicated for: Elecsys Anti-HCV II Immunoassay: Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay ECLIA is intended for use on the cobas e 601 and MODULAR ANALYTICS E170 immunoassay analyzers. Elecsys PreciControl Anti-HCV: Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCV and the Elecsys Anti-HCV II immunoassays on the cobas e 601 and the MODULAR ANALYTICS E170 immunoassay analyzers.