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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP010054
Supplement NumberS001
Date Received12/22/2004
Decision Date03/13/2007
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A NEW INSTRUMENT PLATFORM, AND CHANGING THE ASSAY FROM A QUALITATIVE ASSAY TO A QUANTITATIVE ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS AND IS INDICATED: ELECSYS ANTI-HBS IMMUNOASSAY -FOR THE IN VITRO QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (EDTA). THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY ?ECLIA? IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS. ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAYBE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. ELECSYS PRECICONTROL ANTI-HBS - FOR THE QUALITY CONTROL OF THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS. THE PERFORMANCE OF ELECSYS PRECICONTROL ANTI-HBS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.
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