PMA · Approved
Recalled · Class II · 2018Vitros Immunodiagnostic Products Anti-Hbe Reagent Pack/Anti-Hbe Calibrator/Anti Hbe Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Approved on Jul 20, 2011 through premarket approval, which rests on the device’s own clinical evidence after a 537-day review. It has been recalled once.
- Decided
- Jul 20, 2011
- Review
- 537 days
- Class
- Class II
- Product code
- SEI
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100001 has 17 supplements since 2012: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2012 | 5 |
| 2013 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 1 |
| 2023 | 1 |
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2018 | Class II | Z-0687-2019 | Device Design | The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use. |
No ancestor or descendant has a Class I recall.
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. 2011, 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/P100001 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100001: Vitros Immunodiagnostic Products Anti-Hbe Reagent Pack/Anti-Hbe Calibrator/Anti Hbe Controls.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100001
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026