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
- AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS
- PMA Number
- P060012
- 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- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- September 8, 2006
- Date Received
- March 24, 2006
- Expedited Review
- N
- Docket Number
- 07M-0153
Advisory Committee Statement
APPROVAL FOR THE AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS. THIS DEVICE IS INDICATED FOR: THE AXSYM CORE 2.0 IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES (IGG AND IGM) TO HEPATITIS B VIRUS CORE ANTIGEN (ANTI HBC) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES CONTAINING LITHIUM HEPARIN). THE ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF ACUTE, CHRONIC, OR RESOLVED HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE THE AXSYM CORE 2.0 CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE AXSYM SYSTEM (REAGENT AND INSTRUMENT) WHEN USED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B VIRUS CORE ANTIGEN (ANTI HBC) WHEN USING THE AXSYM CORE 2.0 REAGENT KIT. THE PERFORMANCE OF THE AXSYM CORE 2.0 CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC ASSAYS.
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 |