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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
511 benedict ave.
tarrytown, NY 10591
PMA NumberP100039
Date Received08/17/2010
Decision Date01/20/2012
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 12M-0075
Notice Date 01/24/2012
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for advia centaur anti-hbs2 (ahbs2) assay and advia centaur anti-hbs2 (ahbs2) quality control material for use on the advia centaur and advia centaur xp systems. This device is indicated for: advia centaur anti-hbs2 (ahbs2) assay, the advia centaur anti-hb2 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 of plasma (edta, lithium-heparinized, or sodium-heparinized) and neonatal samples 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 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004