Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
Basic Information
- Device Name
- Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
- Trade Name
- ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS
- PMA Number
- P100039
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- LOM
- Generic Name
- Test, hepatitis b (b core, be antigen, be antibody, b core igm)
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 26, 2013
- Date Received
- September 28, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE AD VIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVEMATERIAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AD VIA CENTAUR ANTIHBS2(AHBS2) ASSAY, ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL, ANDADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL AND IS INDICATED FOR:ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY: THE ADVIA CENTAUR ANTI-HBS2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEAND QUANTITATIVE DETENNINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA (EDTA, LITHIUM-HEPARINIZED, OR SODIUM-HEPARINIZED)AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAYRESULTS MAY BE USED AS AN AID IN THE DETENNINATION 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 SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW ADIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.THIS ASSAY HAS NOT BEEN FDA-CLEARED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS. ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL: FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS2 ASSAY ON THE ADVIACENTAUR SYSTEMS. THE PERFORMANCE OF THE ANTI-HBS2 QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.ADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL: THE ADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL (MCM) IS FOR IN VITRO USE IN THE VERIFICATION OF CALIBRATION AND REPORTABLE RANGE OF THE AD VIA CENTAUR AHBS2 ASSAY.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | FDA class 3 | Unknown |