510(k) · Cleared
ClearedLIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
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)
Cleared on Jun 4, 2026 as substantially equivalent to P190017 (DiaSorin, Inc., 2020) and 1 other predicate after an 87-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Jun 4, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- LOM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P890014 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backP890014 HA-Igmk and Eti-HA-IgmkDiaSorin, Inc. · 1990 · Recalled
- 3 generations backK082050 Liaison Hav Igm Assay, Liaison Control Hav IgmDiaSorin, Inc. · 2008
- 2 generations backK103529 Liaison XL Analyzer Model 10050DiaSorin, Inc. · 2011
- 1 generation backK141116 Liaison XL AnalyzerDiaSorin, Inc. · 2014
- This deviceK260770 LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P890014 | HA-Igmk and Eti-HA-Igmk | DiaSorin, Inc. | 1990 | 1 |
| −3 | K082050 | Liaison Hav Igm Assay, Liaison Control Hav Igm | DiaSorin, Inc. | 2008 | — |
| −2 | K103529 | Liaison XL Analyzer Model 10050 | DiaSorin, Inc. | 2011 | — |
| −1 | K141116 | Liaison XL Analyzer | DiaSorin, Inc. | 2014 | — |
| 0 (this device) | K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P190017 | LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg…Summary page 6…Product Code: LOM JJF Predicate Device: LIAISON® Murex HBsAg Qual (P190017) LIAISON® XL (K141116) Device Description LIAISON® Murex HBsAg Qual The method for… | 2020 |
| * | K141116 | Liaison XL AnalyzerSummary page 6…JJF Predicate Device: LIAISON® Murex HBsAg Qual (P190017) LIAISON® XL (K141116) Device Description LIAISON® Murex HBsAg Qual The method for qualitative determination of HBsAg is a direct sandwich chemilumi… | 2014 |
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.
What does this lineage say?
- The line of descent spans 36 years and passes through 1 company; a new generation was cleared every 11.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
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. 2026, 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 | — |
What is it indicated for?
LIAISON® Murex HBsAg Qual The LIAISON® Murex HBsAg Qual assay is an in vitro chemiluminescent immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 to 21 years) serum and plasma (lithium and sodium heparin, sodium citrate and potassium EDTA) including separator tubes, on the LIAISON® XL and LIAISON® XS Analyzers. Assay results in conjunction with other hepatitis B virus (HBV) serological and…
Read the full statement (346 words)
LIAISON® Murex HBsAg Qual
The LIAISON® Murex HBsAg Qual assay is an in vitro chemiluminescent immunoassay for the
qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 to
21 years) serum and plasma (lithium and sodium heparin, sodium citrate and potassium EDTA)
including separator tubes, on the LIAISON® XL and LIAISON® XS Analyzers. Assay results in
conjunction with other hepatitis B virus (HBV) serological and clinical information, may be used
as an aid in the diagnosis of HBV infection in patients with symptoms of hepatitis or who may be
at risk for HBV infection. The assay may also be used to screen for HBV infection in pregnant
women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period.
This assay is not approved for use in screening blood, plasma or tissue donors.
Caution: U.S. Federal Law restricts this device to sale by or on the order of a licensed
practitioner.
LIAISON® diluteX
The LIAISON® diluteX is an accessory for the LIAISON® XL analyzer.
It is designed to automatically dilute the LIAISON® Wash/System Liquid with purified water
and to distribute both the purified water and the diluted Wash/System Liquid (referred to as
"Wash Buffer") to each connected LIAISON® XL. The LIAISON® diluteX utilizes purified
water (referred to as "sourced water"), which must be supplied to the device. The device
automatically dilutes the LIAISON® Wash/System Liquid, stored on the device, with the sourced
water and distributes both the diluted Wash/System Liquid and the sourced water to the
LIAISON® XL via separate tubes directly into the analyzer’s tanks.
For professional use only.
LIAISON® XL
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA)
analyzer for in vitro diagnostic analysis of CLIAs on human specimens cleared for use on the analyzer.
It is only to be used with FDA cleared chemiluminescent immunoassays that are marketed by DiaSorin for the
LIAISON® XL Analyzer. The analyzer can be connected to a third party Laboratory Automation System (LAS) which
has been previously cleared for use with FDA cleared assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260770: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260770
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026