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 HBsAg II Auto Confirm
- PMA Number
- P160019
- Supplement Number
- S011
- 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 19, 2020
- Date Received
- November 27, 2019
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for 1) the Elecsys HBsAg II Auto Confirm: Immunoassay for in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, lithium heparin, K2-EDTA, sodium citrate) samples repeatedly reactive when tested with the Elecsys HBsAg II assay. The electrochemiluminescence immunoassay ECLIA is intended for use on cobas e immunoassay analyzers;2) the PreciControl HBsAg Auto Confirm: PreciControl HBsAg Auto Confirm is used for quality control of the Elecsys HBsAg II Auto Confirm Immunoassay on the cobas e 801 immunoassay analyzer; and 3) the PreciControl HBsAg II: PreciControl HBsAg II is used for quality control of the Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm immunoassays on the cobas e immunoassay analyzers. The performance of PreciControl HBsAg II has not been established with any other HBsAg assay.
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 |