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
- IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS
- PMA Number
- P010052
- Supplement Number
- S004
- 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
- December 16, 2009
- Date Received
- February 25, 2008
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR IMMULITE/ IMMULITE 1000 ANDIMMULITE 2000 ANTI HBS ASSAY. THE DEVICE IS INDICATED FOR:IMMULITE/ IMMULITE 1000FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE OR IMMULITE 1000 ANALYZERS FOR THEQUALITATIVE AND QUANTITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN(ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED). ASSAY RESULTS MAY BE USED AS AN AID IN THEDETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR 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 WITHHBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALSDISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.IMMULITE 2000FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 SYSTEMS AUTOMATED IMMUNOASSAYANALYZERS FOR THE QUALITATIVE AND QUANTITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS BSURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED). ASSAY RESULTS MAY BE USEDAS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING I-IBV 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 A DIFFERENTIALDIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY ISUNKNOWN.
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 |