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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.
 
DeviceARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
DEPT 09V6, BLDG. AP5-2
ABBOTT PARK, IL 60064-6088
PMA NumberP110029
Date Received07/26/2011
Decision Date04/12/2012
Product Code LOM 
Docket Number 12M-0372
Notice Date 04/17/2012
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ARCHITECT HBSAG QUALITATIVE, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY MANUAL DILUENT, ARCHITECT HBSAG QUALITATIVE CALIBRATORS, AND ARCHITECT HBSAG QUALITATIVE CONTROLS. THIS DEVICE IS INDICATED FOR: ARCHITECT HBSAG QUALITATIVE - THE ARCHITECT HBSAG QUALITATIVE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA AND NEONATE SERUM. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK FOR ACQUIRING HEPATITIS BDURING THE PERINATAL PERIOD. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION. NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS. ARCHITECT HBSAG QUALITATIVE CONFIRMATORY - THE ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA AND NEONATE SERUM BY MEANS OF SPECIFIC ANTIBODY NEUTRALIZATION. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION. NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS. (FOR ADDITIONAL INFORMATION, PLEASE REFER TO APPROVAL ORDER).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 
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