PMA · Approved
ApprovedElecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics, Inc. · LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approved on Dec 23, 2016 through premarket approval, which rests on the device’s own clinical evidence after a 175-day review.
- Decided
- Dec 23, 2016
- Review
- 175 days
- Class
- Class II
- Product code
- LOM
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P160019 has 19 supplements since 2017: 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 |
|---|---|
| 2017 | 5 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 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)
No FDA recall names this device.
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. 2016, this device’s year, is highlighted.
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/P160019 · printed Nov 6, 2026
Cite this page
510(k) Report. “P160019: Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P160019
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026