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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 NumberP100032
Supplement NumberS007
Date Received09/04/2012
Decision Date12/19/2013
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 migration of claims from the fda approved elecsys anti-hbc immunoassay and elecsys precicontrol anti-hbc on the elecsys 2010 analyzer to the cobas e 411 immunoassay analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hbc immunoassay and elecsys precicontrol anti-hbc and is indicated for: elecsys anti-hbc immunoassay the elecsys anti-hbc immunoassay is intended for the in vitro qualitative determination of total antibodies to hepatitis b core antigen (anti-hbc) in human serum and plasma (lithium heparin, sodium citrate, k2-edta) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis b (hbv) infection. The detection of total anti-hbc is indicative of a laboratory diagnosis for hbv infection. Further hbv serological marker testing is required to define the specific disease state. The elecsys anti-hbc immunoassay's performance has not been established for the monitoring of hbv disease or therapy. The electrochemiluminescence immunoassay "eclia" is intended for use on the elecsys 2010 and the cobas e 411 immunoassay analyzers. Elecsys precicontrol anti-hbc elecsys precicontro1 anti-hbc is used for quality control of the elecsys anti-hbc immunoassay on the elecsys 2010 and the cobas e411 immunoassay analyzers.