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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)
333 coney street
walpole, MA 02032-1516
PMA NumberP030040
Date Received09/11/2003
Decision Date08/06/2004
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 05M-0158
Notice Date 05/02/2005
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the advia centaur hbc igm. Hbc igm ready pack reagents: this device is indicated for use for the advia centaur hbc igm assay and is an in vitro diagnostic test for the qualitative determination if igm response to hepatitis b virus core antigen in human serum and plasma (edta or lithium or sodium heparinized) using the advia centaur system. The assay uses recombinant hbc antigen. This assay may be used in combination with other hepatitis b virus (hbv) market 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. Hbc igm quality control materials: the controls are indicated for in vitro diagnostic use in monitoring the performance of the hbc igm assay on the adviua centaur systems. The performance of the hbc igm quality control material has not been established with any other anti-hbc igm assays.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002 S003 S004 S005 S006 S007 S008 S009 S010