ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)

FDA Premarket Approval P210019

Pre-market Approval Supplement Details

DeviceADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSiemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP210019 Date Received05/11/2021 Decision Date07/27/2022 Product Code LOM  Advisory Committee Microbiology Expedited Review Granted? No
Date Received2021-05-11
Decision Date2022-07-27
PMAP210019
SupplementS
Product CodeLOM 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination ProductNo
Applicant AddressSiemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
tarrytown, NY 10591 PMA NumberP210019 Date Received05/11/2021 Decision Date07/27/2022 Product Code LOM  Advisory Committee Microbiology Expedited Review Granted? No Combination ProductNo Approval Order Statement  
ADVIA Centaur® HBc Total 2 (HBcT2) AssayThe ADVIA Centaur HBc Total 2 (HBcT2) Assay Is An In Vitro Diagnostic Immunoassay For Use In The Qualitative Determination Of Total Antibodies To The Core Antigen Of The Hepatitis B Virus (HBV) In Human Adult Serum And Plasma (EDTA, Lithium Heparin, And Sodium Heparin) Using The ADVIA Centaur XP And ADVIA Centaur XPT Systems.This Assay Can Be Used As An Aid In The Diagnosis Of Adults With Acute Or Chronic Hepatitis B Virus (HBV) Infection, And In The Determination Of The Clinical Status Of HBV-infected Individuals In Conjunction With Other HBV Serological Markers, For The Laboratory Diagnosis Of HBV Disease Associated With HBV Infection. This Assay Can Also Be Used As An Aid In The Differential Diagnosis In Individuals Displaying Signs And Symptoms Of Hepatitis In Whom Etiology Is Unknown.This Assay Is Not Intended For Screening Donors Of Blood Or Blood Products Or Human Cells, Tissues, And Cellular And Tissue-based Products (HCT/Ps).ADVIA Centaur® HBc Total 2 Quality Control (HBcT2 QC)The ADVIA Centaur® HBc Total 2 (HBcT2) Quality Control Material Is For In Vitro Diagnostic Use For Monitoring The Performance Of The ADVIA Centaur HBc Total 2 (HBcT2) Assay Using The ADVIA Centaur Systems.The Performance Of The ADVIA Centaur HBcT2 Quality Control Material Has Not Been With Any Other Anti-HBc Total Assay.Atellica IM® HBc Total 2 (HBcT2) AssayThe Atellica IM HBc Total 2 (HBcT2) Assay Is An In Vitro Diagnostic Immunoassay For Use In The Qualitative Determination Of Total Antibodies To The Core Antigen Of The Hepatitis B Virus (HBV) In Human Adult Serum And Plasma (EDTA, Lithium Heparin, And Sodium Heparin) Using The Atellica IM Analyzer.This Assay Can Be Used As An Aid In The Diagnosis Of Adults With Acute Or Chronic Hepatitis B Virus (HBV) Infection And In The Determination Of The Clinical Status Of HBV-infected Individuals In Conjunction With Other HBV Serological Markers, For The Laboratory Diagnosis Of HBV Disease Associated With HBV Infection. This Assay Can Also Be Used As An Aid In The Differential Diagnosis In Individuals Displaying Signs And Symptoms Of Hepatitis In Whom Etiology Is Unknown.This Assay Is Not Intended For Screening Donors Of Blood Or Blood Products Or Human Cells, Tissues, And Cellular And Tissue-based Products (HCT/Ps).Atellica IM® HBc Total 2 Quality Control (HBcT2 QC)The Atellica IM HBc Total 2 (HBcT2) Quality Control Material Is For In Vitro Diagnostic Use For Monitoring The Performance Of The Atellica IM HBc Total 2 (HBcT2) Assay Using The Atellica IM Systems.The Performance Of The Atellica IM HBcT2 Quality Control Material Has Not Been With Any Other Anti-HBc Total Assay. Approval OrderApproval Order SummarySummary Of Safety And Effectiveness LabelingLabeling
Supplements:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P210019Original Filing

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