|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ADVIA CENTAUR ANTI-HBS (AHBS)|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for adding quantitative determination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric serum or plasma to the intended use. The device, as modified, will be marketed under the trade name advia centaur® and advia centaur® xp anti-hbs assay and is indicated for: the advia centaur anti-hbs assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric 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 i hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.