PMA · Approved
Recalled · Class II · 2023Vitros Immunodiagnostic Products:Anti-HBS Reagent Pack/Anti-HBS Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Approved on Sep 29, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 211-day review. It has been recalled 2 times.
- Decided
- Sep 29, 2000
- Review
- 211 days
- Class
- Class II
- Product code
- SEI
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P000014 has 36 supplements since 2001: 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 |
|---|---|
| 2001 | 4 |
| 2003 | 2 |
| 2004 | 4 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 2 |
| 2012 | 2 |
| 2014 | 2 |
| 2015 | 3 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 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 27, 2023 | Class II | Z-0772-2024 | Nonconforming Material/Component | Affected lots may experience increased calibration failures or an increase in falsely elevated results. |
| Oct 25, 2013 | Class II | Z-0557-2014 | Other | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results. |
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.
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/P000014 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000014: Vitros Immunodiagnostic Products:Anti-HBS Reagent Pack/Anti-HBS Calibrators.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000014
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026