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 IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC
- PMA Number
- P100031
- 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
- June 22, 2011
- Date Received
- July 30, 2010
- Expedited Review
- N
- Docket Number
- 11M-0502
Advisory Committee Statement
APPROVAL FOR THE ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUM-HEPARIN, SODIUM-CITRATE, K2-EDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ELECSYS ANTI-HBC IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING HBV DISEASE OR THERAPY. THE ELECTRO- CHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE MODULAR ANALYTICS EI70 IMMUNOASSAY ANALYZER. THE ELECSYS PRECI-CONTROL ANTI-HBC IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYTICS E170 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 |