|Trade Name||ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS & CONTROL MATERIAL|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|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 anti-hbs ready pack reagents and calibrators. The device, as modified, will be marketed under the trade name advia centaur's) and advia centaur xp anti-hbs assay and is indicated for: advia centaur anti-hbs ready pack reagents and calibrator the advia centaur anti-hbs assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis b surface antigen in human serum or plasma (edta, or heparinized) using the advia centaur and advia centaur xp systems. The assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection in individuals prior to or following hbv vaccination or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay results will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Advia centaur anti-hbs control material for monitoring the performance of the anti-hbs assay on the advia centaur and advia centaur xp systems.