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| Device | ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS |
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| Generic Name | Hepatitis a test (antibody and igm antibody) |
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| Regulation Number | 866.3310 |
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| Applicant | Bayer Healthcare, Diagnostics Division
511 Benedict Ave.
New York, NY 10591 |
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| PMA Number | P040017 |
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| Date Received | 04/01/2004 |
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| Decision Date | 03/07/2005 |
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| Reclassified Date | 02/09/2006 |
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| Product Code |
LOL |
| Docket Number | 05M-0110 |
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| Notice Date | 03/21/2005 |
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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 HAV TOTAL ASSAY AND QUALITY CONTROL MATERIALS. HAV TOTAL ASSAY INDICATION FOR USE: THE ADVIA CENTAUR HAV TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS A VIRUS (ANTI-HAV ) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THIS ANTI-HAV ASSAY IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION. HAV TOTAL QUALITY CONTROL MATERIALS INDICATION FOR USE: FOR MONITORING THE PERFORMANCE OF THE HAV TOTAL ASSAY ON ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HAV TOTAL QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HAV 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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