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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
PMA NumberP100039
Supplement NumberS001
Date Received04/30/2012
Decision Date10/03/2013
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the advia centaur anti-hbs2 (ahbs2) assay and advia centaur anti-hbs2 (ahbs2) quality control material for use on the advia centaur cp instrument. The device, as modified, will be marketed under the trade name advia centaur anti-hbs2 (ahbs2) assay and advia centaur anti-hbs2 (ahbs2) quality control material and is indicated for: advia centaur anti-hbs2 (ahbs2) assay - the advia centaur anti-hbs2 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 (edt a, lithium-heparinized, or sodium-heparinized) and neonatal samples using the advia centaur cp system. 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 result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. This assay has not been fda-cleared or approved for the screening of blood or plasma donors advia centaur anti-hbs2 (ahbs2) quality control material - for in vitro. Diagnostic use in monitoring the performance of the anti-hbs2 assay on the advia centaur systems. The performance of the anti-hbs2 quality control material has not been established with any other anti-hbs assays.