| 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. |
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| Device | ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit |
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| Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | Abbott Laboratories
100 Abbott Park Road
DEPT: 09AA BLDG: AP8-1
Abbott Park, IL 60064 |
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| PMA Number | P210003 |
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| Date Received | 02/08/2021 |
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| Decision Date | 08/10/2022 |
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| Product Code |
LOM |
| Docket Number | 22M-1906 |
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| Notice Date | 08/15/2022 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the ARCHITECT HBsAg NEXT Qualitative Reagent Kit. The HBsAg Next Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 years to 21 years of age) serum, serum separator tube, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, sodium heparin) on the ARCHITECT i System.The assay may also be used to screen for hepatitis B virus (HBV) infection in pregnant women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with 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. ARCHITECT HBsAg NEXT Confirmatory Reagent Kit The HBsAg Next Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 years to 21 years of age) serum, serum separator, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, sodium heparin) by means of specific antibody neutralization on the ARCHITECT i SystemAssay 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.It is intended to be used for the confirmation of samples found to be repeatedly reactive by HBsAg Next Qualitative.It is intended to be used for the confirmation of samples found to be repeatedly reactive by HBsAg Next Qualitative.ARCHITECT HBsAg NEXT Qualitative CalibratorsThe HBsAg Next Qualitative Calibrators are for the calibration of the ARCHITECT i System when used for qualitative determination and confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma.ARCHITECT HBsAg NEXT Qualitative ControlsThe HBsAg Next Qualitative Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the qualitative detection and for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma.ARCHITECT HBsAg NEXT Confirmatory Manual DiluentThe HBsAg Next Confirmatory Manual Diluent is used for manually diluting specimens for testing on the ARCHITECT i System. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 |
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