Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Basic Information
- Product Code
- SEI
- Device Class
- FDA class 2
- Regulation Number
- 866.3173
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260049 | Elecsys Anti-HBc IgM | Apr 07, 2026 | Substantially Equivalent | Roche Diagnostics |
| K260046 | Elecsys Anti-HBc II | Apr 07, 2026 | Substantially Equivalent | Roche Diagnostics |
| K254059 | Access anti-HBc IgM | Mar 13, 2026 | Substantially Equivalent | Beckman Coulter, Inc. |
| K253687 | Access anti-HBc Total | Feb 19, 2026 | Substantially Equivalent | Beckman Coulter, Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.