FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys Anti-HBc II
K Number: K260046
·
Decision Apr 7, 2026
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
3
Applicant Total
183
Review Days
90
Basic Information
- Device Name
- Elecsys Anti-HBc II
- K Number
- K260046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3173
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- January 7, 2026
- Decision Date
- April 7, 2026
- Product Code
- SEI
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SEI), ordered by most recent decision date.
Elecsys Anti-HBc IgM
FDA 510(k)
FDA Class 2
·Microbiology
Access anti-HBc IgM
FDA 510(k)
FDA Class 2
·Microbiology
Access anti-HBc Total
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Roche Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring system | Jun 12, 2026 | Substantially Equivalent |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Apr 13, 2026 | Substantially Equivalent |
| K260048 | Elecsys Anti-HAV IgM | Apr 7, 2026 | Substantially Equivalent |
| K260049 | Elecsys Anti-HBc IgM | Apr 7, 2026 | Substantially Equivalent |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Apr 2, 2026 | Substantially Equivalent |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Feb 12, 2026 | Substantially Equivalent |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Feb 12, 2026 | Substantially Equivalent |
| K253839 | Elecsys Anti-SARS-CoV-2 | Dec 17, 2025 | Substantially Equivalent |
| K253188 | CoaguChek XS Plus System | Oct 24, 2025 | Substantially Equivalent |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Oct 8, 2025 | Substantially Equivalent |