| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS |
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| Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516 |
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| PMA Number | P030040 |
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| Supplement Number | S011 |
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| Date Received | 07/05/2016 |
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| Decision Date | 12/25/2016 |
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| Product Code |
LOM |
| Advisory Committee |
Microbiology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for a claim to test a pediatric population with the FDA approved ADVIA Centaur® HBc IgM ReadyPack Reagents and ADVIA Centaur® HBc IgM Quality Control Materials. The device, as modified, will be marketed under the trade name ADVIA Centaur® HBc IgM Assay and is indicated for:ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systemsThe ADVIA Centaur® HBc IgM (aHBcM) assay is an in vitro diagnostic test for the qualitative determination of lgM response to hepatitis B virus core antigen in human pediatric (2 through 21 years) and adult serum and plasma (EDTA or lithium or sodium heparinized) using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The assay uses recombinant HBc antigen. This assay may be used in combination with other hepatitis B virus (HBV) marker assays to define the clinical status of known HBV infected patients or can be combined with other HBV, HAV (hepatitis A virus), and HCV (hepatitis C virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis.Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age. Assay performance characteristics have not been established when the ADVIA Centaur HBc IgM assay is used in conjunction with other manufacturers' assays for specific HBV serological markers.ADVIA Centaur CP systemThe ADVIA Centaur® HBc IgM assay is an in vitro diagnostic test for the qualitative determination of IgM response to hepatitis B virus core antigen in human pediatric (2 through 21 years) and adult serum and plasma (EDTA or lithium or sodium heparinized) using the ADVIA Centaur CP System. The assay uses recombinant HBc antigen. This assay may be used in combination with other hepatitis B virus (HBV) marker assays to define the clinical status of known HBV infected patients or can be combined with other HBV, HAV (hepatitis A virus), and HCV (hepatitis C virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis.Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.Assay performance characteristics have not been established when the ADVIA Centaur HBc IgM assay is used in conjunction with other manufacturers' assays for specific HBV serological markers.ADVIA Centaur® HBc IgM Quality Control MaterialsFor monitoring the performance of the HBc IgM assay using the ADVIA Centaur® systems. The performance of the HBc IgM quality control material has not been established with any other anti-HBc IgM assays. |
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