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-HBe, PreciControl Anti-HBe
- PMA Number
- P190005
- 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
- February 3, 2021
- Date Received
- March 1, 2019
- Expedited Review
- N
- Docket Number
- 21M-0178
Advisory Committee Statement
Approval for the Elecsys Anti-HBe The device is an immunoassay for the in vitro qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human adult serum or plasma (potassium EDTA, lithium heparin, sodium citrate, sodium heparin) from individuals with symptoms of hepatitis or at risk for hepatitis B virus (HBV) infection. Assay results, in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis B virus (HBV) infection in patients with symptoms of hepatitis or who may be at risk for HBV infection. A reactive test is presumptive laboratory evidence of HBV seroconversion. Further HBV serological marker testing is required to define the specific disease state. The PreciControl Anti-HBe is used for quality control of the Elecsys Anti-HBe immunoassay on the cobas e 602 immunoassay analyzer. The performance of PreciControl Anti-HBe has not been established with any other anti-HBe 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 |