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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 NumberP030029
Supplement NumberS005
Date Received03/03/2009
Decision Date04/09/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product 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.