|Trade Name||ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Generic Name||total antibody to hepatitis b core antigen(anti-hbc total assay)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the transition of the advia centaur hbc total assay to a new platform in the centaur family of instruments, the centaur cp. The device, as modified, will be marketed under the trade name advia centaur hbc total assay and is indicated for: advia centaur hbc total readypack reagents on the centaur cp analyzer: the advia centaur hbc total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus (hbc total) in human serum or plasma (potassium edta, or lithium or sodium heparinized) using the advia centaur cp system. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Advia centaur hbc total quality control materials on the centaur cp analyzer: for monitoring the performance of the hbc total assay on the advia centaur systems. The performance of the hbc total quality control material has not been established with any other anti-hbc total assays.