PMA P030029S003
- Device
- ADVIA CENTAUR AHBS
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030029
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2009-07-31
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR ANTI-HBS ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP.ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMANSERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS(HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICALMARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. AREACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS ANDSYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS ARE INTENDED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR AHBS
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030029
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2009-07-31
- Decision code
- APPR
- Date received
- 2008-08-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR ANTI-HBS ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP.ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMANSERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS(HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICALMARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. AREACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS ANDSYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS ARE INTENDED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.