Axsym Core 2.0 and Axsym Core 2.0 Controls
FDA premarket approval P060012 · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval
- Applicant
- Abbott Laboratories, Inc.
- Received
- March 24, 2006
- Decision date
- September 8, 2006 (APWD)
- Supplements
- 10, latest December 5, 2012
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order 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.