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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.
 
DeviceIMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSiemens Healthcare Diagnostics Products, LTD
GLYN RHONWY
LLANBERIS, CAERNARFON LL55
PMA NumberP010052
Supplement NumberS004
Date Received02/25/2008
Decision Date12/16/2009
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 IMMULITE/ IMMULITE 1000 ANDIMMULITE 2000 ANTI HBS ASSAY. THE DEVICE IS INDICATED FOR:IMMULITE/ IMMULITE 1000FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE OR IMMULITE 1000 ANALYZERS FOR THEQUALITATIVE AND QUANTITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN(ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED). ASSAY RESULTS MAY BE USED AS AN AID IN THEDETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITHHBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALSDISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.IMMULITE 2000FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 SYSTEMS AUTOMATED IMMUNOASSAYANALYZERS FOR THE QUALITATIVE AND QUANTITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS BSURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED). ASSAY RESULTS MAY BE USEDAS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING I-IBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIALDIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY ISUNKNOWN.
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