|Trade Name||ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Applicant||SIEMENS HEALTHCARE DIAGNOSTICS|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for adding advia centaur xp instrument to the intended use of the approved device advia centaur hcv assay. The device, as modified, will be marketed under the trade name advia centaur hcv assay and is indicated for: advia centaur hcv assay: the advia centaur hcv assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin g (igg) antibodies to hepatitis c virus (hcv) in human serum and plasma (edta, lithium or sodium heparin) using the advia centaur and advia centaur xp systems. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis c infection. Advia centaur hcv quality controls: for in vitro diagnostic use in monitoring the performance of the hcv assay on the advia centaur systems. The performance of the hcv quality control material has not been established with any other anti-hcv assays.