PMA · Approved
ApprovedArchitect Core Reagent Kit, Architect Core Calibrator and Architect Core Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Approved on Apr 10, 2009 through premarket approval, which rests on the device’s own clinical evidence after a 225-day review. 2 later devices descend from it.
- Decided
- Apr 10, 2009
- Review
- 225 days
- Class
- Class II
- Product code
- SEI
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
- This deviceP080023 Architect Core Reagent Kit, Architect Core Calibrator and Architect…Abbott Laboratories · 2009
- Descendant · cites it directly · 0 of its ownK260046 Elecsys Anti-HBc IIRoche Diagnostics · 2026
- Descendant · cites it directly · 0 of its ownK253687 Access anti-HBc TotalBeckman Coulter, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P080023 | Architect Core Reagent Kit, Architect Core Calibrator and Architect Core… | Abbott Laboratories | 2009 | — |
| +1 | K260046 | Elecsys Anti-HBc II | Roche Diagnostics | 2026 | — |
| +1 | K253687 | Access anti-HBc Total | Beckman Coulter, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K260046 (Roche Diagnostics, 2026) has gone furthest, with 0 descendants of its own.
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. 2009, 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 | — |
https://510kreport.com/device/P080023 · printed Nov 6, 2026
Cite this page
510(k) Report. “P080023: Architect Core Reagent Kit, Architect Core Calibrator and Architect Core Controls.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P080023
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026