Food and Drug Administration Approves Spate of New Medical Devices

摘要

Food and Drug Administration (FDA) has been busy approving new (original) devices. Among the recent approvals are the following: ? COBAS TaqMan HBV Test for use with the High Pure System, Roche Molecular Systems Inc, Pleasanton, California. This device is indicated for in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human serum or plasma (ethylenediaminetetraacetic acid), using the High Pure Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 Analyzer for automated amplification and detection. The test is intended for use as an aid in the management of patients with chronic HBV infection undergoing antiviral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.