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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 Nameigm antibody to hepatitis b core antigen
PMA NumberP030040
Supplement NumberS002
Date Received08/11/2008
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 - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the transition of the advia centaur hbc igm 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 igm assay and is indicated for: advia centaur hbc igm readypack reagents on the centaur cp analyzer: the advia centaur hbc igm assay is an in vitro diagnostic test for the qualitative determination of igm response to hepatitis b virus core antigen in human serum and plasma (edta or lithium or sodium heparinized) using the advia centaur cp system. The assay uses recombinant hbc antigen. This assay may be used in combination with other hepatitis b virus (hbv) marker assays to define the clinical status of known hbv infected patients or can be combined with other hbv, hav (hepatitis a virus), and hcv (hepatitis c virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis. Assay performance characteristics have not been established for immunocompro-mised or immunosuppressed patients, cord blood, neonatal specimens, infants, or children. Assay performance characteristics have not been established when the advia centaur hbc igm assay is used in conjunction with other manufacturers' assays for specific hbv serological markers. Advia centaur hbc igm quality control materials on the centaur cp analyzer: for monitoring the performance of the hbc igm assay using the advia centaur systems. The performance of the hbc igm quality control material has not been established with any other anti-hbc igm assays.