PMA · Approved
ApprovedLIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approved on Aug 29, 2020 through premarket approval, which rests on the device’s own clinical evidence after a 428-day review. 1 later device descends from it.
- Decided
- Aug 29, 2020
- Review
- 428 days
- Class
- Class II
- Product code
- LOM
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceP190017 LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and…DiaSorin, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK260770 LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P190017 | LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL… | DiaSorin, Inc. | 2020 | — |
| +1 | K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | 2026 | 0 |
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, K260770 (DiaSorin, Inc., 2026) has gone furthest, with 0 descendants of its own.
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. 2020, 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/P190017 · printed Nov 6, 2026
Cite this page
510(k) Report. “P190017: LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P190017
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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