510(k) · Cleared
ClearedAccess anti-HBc IgM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Cleared on Mar 13, 2026 as substantially equivalent to P060035 (Abbott Laboratories, 2007) after an 86-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Mar 13, 2026
- Review
- 86 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 deviceK254059 Access anti-HBc IgMBeckman Coulter, Inc. · 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) | K254059 | Access anti-HBc IgM | Beckman Coulter, Inc. | 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 K260049 Elecsys Anti-HBc IgMscore 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…irus antibody assay Classification Regulation: 21 CFR 866.3173 Class: II Classification Product Code: SEI Predicate Device Device Name: ARCHITECT CORE-M 510(k) Numbers: P060035 Purpose for Submission: New device market clearance of Access anti-HBc IgM assay for use on the DxI 9000 Immunoassay Analyzer D… | 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?
The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human pediatric (3 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose…
Read the full statement (149 words)
The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative
detection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human pediatric (3 through 21 years) and
adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2)
EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)]
using the DxI 9000 Access Immunoassay Analyzer.
The Access anti-HBc IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis B
virus (HBV) infection in individuals with signs and symptoms of hepatitis, when used in conjunction with other
serological and clinical information.
The Access anti-HBc IgM assay is for use on the DxI 9000 Access Immunoassay Analyzer only.
This assay is not intended for the screening of blood, plasma, and cell or tissue donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254059 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254059: Access anti-HBc IgM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254059
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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