510(k) · Cleared
ClearedElecsys Anti-HBc IgM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Cleared on Apr 7, 2026 as substantially equivalent to P060035 (Abbott Laboratories, 2007) after a 90-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Apr 7, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- SEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P060035 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backP060035 Architect Core-M Reagent Kit/Calibrators/ControlsAbbott Laboratories · 2007
- This deviceK260049 Elecsys Anti-HBc IgMRoche Diagnostics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P060035 | Architect Core-M Reagent Kit/Calibrators/Controls | Abbott Laboratories | 2007 | — |
| 0 (this device) | K260049 | Elecsys Anti-HBc IgM | Roche Diagnostics | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SEI device
- #1 K260046 Elecsys Anti-HBc IIscore 11.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P060035 | Architect Core-M Reagent Kit/Calibrators/ControlsSummary page 5…i-HBc IgM Classification Name Hepatitis B virus antibody assays Product Codes SEI, 866.3173 Predicate Devices Abbott ARCHITECT CORE-M (P060035) Establishment Registration Roche Diagnostics Operations Inc. 1823260… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate P060035.
How does its category compare?
All SEI devicesSEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SEI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · SEI
90in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SEI
No recall names SEI since 2007.
Adverse event reports per year · SEI
No MAUDE report names SEI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 4 | — | 0 | 0 |
| 2021 | 3 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 4 | 90 | 0 | — |
What is it indicated for?
Immunoassay for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 through 21 years of age) patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is…
Read the full statement (110 words)
Immunoassay for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 through 21 years of age) patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. The immunoassay’s performance has not been established for the monitoring of HBV disease or therapy.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260049: Elecsys Anti-HBc IgM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260049
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026