| 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 | ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) |
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| Generic Name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
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| Regulation Number | 866.3173 |
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| Applicant | Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York, NY 10591 |
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| PMA Number | P210019 |
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| Date Received | 05/11/2021 |
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| Decision Date | 07/27/2022 |
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| Reclassified Date | 10/20/2025 |
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| Product Code |
SEI |
| Docket Number | 22M-1740 |
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| Notice Date | 07/29/2022 |
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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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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the ADVIA Centaur® HBc Total 2 (HBcT2) assay. The 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 Approval for 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).Approval for the 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.Approval for the Atellica IM® HBc Total 2 (HBcT2) assay.The 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).Approval for the 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 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 |
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