- Device
- ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS & CONTROL MATERIAL
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P030029
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2009-04-09
- Decision code
- APPR
- Date received
- 2009-03-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICE ADVIA CENTAUR ANTI-HBS READY PACK REAGENTS AND CALIBRATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR'S) AND ADVIA CENTAUR XP ANTI-HBS ASSAY AND IS INDICATED FOR:ADVIA CENTAUR ANTI-HBS READY PACK REAGENTS AND CALIBRATORTHE 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 AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OFSUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWINGHBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITHOTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATEDWITH HBV INFECTION. A REACTIVE ASSAY RESULTS WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.ADVIA CENTAUR ANTI-HBS CONTROL MATERIALFOR MONITORING THE PERFORMANCE OF THE ANTI-HBS ASSAY ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS.