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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDIASORIN ETI MAK-2 PLUS ASSAY
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285
PMA NumberP990038
Date Received07/02/1999
Decision Date03/30/2001
Withdrawal Date 10/10/2023
Product Code LOM 
Docket Number 01M-0451
Notice Date 10/09/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE DIASORIN ETI-MAK-2 PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-MAK-2 PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-MAK-2 PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE DETECTION OF HBSAG IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HEPATITIS B VIRUS (HBV) INFECTION, EITHER ACUTE OR CHRONIC. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ETI-MAK-2 PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S014  S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S015 S017 S018 S019 S020 S021 S022 S023 S024 S025 S027 
S028 S029 S030 S031 S032 
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