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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.
 
Trade NameROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP990012
Supplement NumberS001
Date Received09/29/2004
Decision Date03/13/2007
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a new instrument platform. The devices, as modified, will be marketed under the trade name elecsys hbsag immunoassay, elecsys hbsag confirmatory test and elecsys precicontrol hbsag and is indicated: elecsys hbsag immunoassay - for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (sodium heparin, k3-edta, sodium citrate). Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis b. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates at high risk of acquiring hbv during the perinatal period. The electrochemilumi-nescence immunoassay ?eclia? is intended for use on the roche elecsys 2010 and modular analytics e170 (elecsys module) immunoassay analyzers. The elecsys hbsag confirmatory test - for the in vitro qualitative confirmation of the presence of hepatitis b surface antigen in human serum and plasma (sodium heparin, edta-k3, sodium citrate) samples repeatedly reactive when tested with the elecsys hbsag immunoassay. The elecsys hbsag confirmatory immunoassay is intended for use on the roche elecsys 2010 and modular analytics e170 immunoassay analyzers. Elecsys precicontrol hbsag - for quality control of the elecsys hbsag immunoassay on the elecsys 2010 and modular analytics e170 analyzers when testing human serum. The performance of the precicontrol hbsag has not been established with any other hbsag assay.
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