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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)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
333 coney street
walpole, MA 02032-1516
PMA NumberP040004
Supplement NumberS002
Date Received08/26/2008
Decision Date10/20/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the transition of the advia centaur hbc total assay to a new platform in the centaur family of instruments, the centaur cp. The device, as modified, will be marketed under the trade name advia centaur hbc total assay and is indicated for:advia centaur hbc total readypack reagents on the centaur cp analyzer:the advia centaur hbc total assay is an in vitro diagnostic test for the qualitativedetermination of total antibodies to the core antigen of the hepatitis b virus (hbc total)in human serum or plasma (potassium edta, or lithium or sodium heparinized) using the advia centaur cp system. This assay can be used as an aid in the diagnosis ofindividuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. This assay can also be used as an aid in the differential diagnosis inindividuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Advia centaur hbc total quality control materials on the centaur cp analyzer:for monitoring the performance of the hbc total assay on the advia centaur systems. The performance of the hbc total quality control material has not beenestablished with any other anti-hbc total assays.