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
- ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
- PMA Number
- P110022
- 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
- October 26, 2011
- Date Received
- May 9, 2011
- Expedited Review
- N
- Docket Number
- 11M-0786
Advisory Committee Statement
APPROVAL FOR THE ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM FOR USE ON THE COBAS E 601 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR: THE ELECSYS ANTI-HBC IGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN. SODIUM HEPARIN, SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (1IBV) INJECTION. THE PRESENCE OF ANTI-HBC IGM. IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, IS INDICATIVE OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS ANTI-HBC IGM IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.THE ELECTROCHEMILU-MINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE COBAS E 601 IMMUNOASSAY ANALYZER. PRECICONTROI ANTI-HBC IGM ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IGM IMMUNOASSAY ON THE COBAS E 601 IMMUNOASSAY ANALYZER.
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 |