PMA · Approved
Recalled · 2007Vitros Immunodiagnostic Products/Hbsag Reagent Pack,Vitros Immunodiagnostic Products Confirmatory Kit, and Vitros Immunr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approved on Apr 27, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 177-day review. It has been recalled once.
- Decided
- Apr 27, 2001
- Review
- 177 days
- Class
- Class II
- Product code
- LOM
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P000044 has 40 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 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 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 LOM? 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 LOM device
- #1 K260770 LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON…score 12.3 · 4 generations · no Class I recall
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 |
|---|---|---|---|---|
| Feb 1, 2007 | Not classified | Z-0747-2007 | Other | Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LOM devicesLOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOM
68in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOM
Too few LOM 510(k)s in any year since 2007 to give a median.
Recalls per year · LOM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOM
382in 2025
MAUDE reports naming product code LOM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | — | 10 | 72 |
| 2008 | 22 | — | 1 | 64 |
| 2009 | 48 | — | 2 | 128 |
| 2010 | 46 | — | 1 | 93 |
| 2011 | 119 | — | 0 | 132 |
| 2012 | 125 | — | 1 | 140 |
| 2013 | 46 | — | 2 | 174 |
| 2014 | 46 | — | 2 | 129 |
| 2015 | 38 | — | 0 | 139 |
| 2016 | 46 | — | 0 | 146 |
| 2017 | 57 | — | 0 | 88 |
| 2018 | 73 | — | 2 | 112 |
| 2019 | 36 | — | 0 | 191 |
| 2020 | 49 | — | 0 | 139 |
| 2021 | 57 | — | 0 | 147 |
| 2022 | 69 | — | 0 | 139 |
| 2023 | 63 | — | 1 | 163 |
| 2024 | 52 | — | 0 | 197 |
| 2025 | 68 | — | 0 | 382 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/P000044 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000044: Vitros Immunodiagnostic Products/Hbsag Reagent Pack,Vitros Immunodiagnostic Products Confirmatory Kit, and Vitros Immunr.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000044
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026