De Novo · Granted
GrantedLIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · SGW Device To Detect Antibodies To Hepatitis D Virus
Granted on Dec 23, 2025 as a new device type through De Novo after a 146-day review.
- Decided
- Dec 23, 2025
- Review
- 146 days
- Class
- Class II
- Product code
- SGW
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SGW? 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
Does it have a predicate?
De Novo 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 SGW devicesSGW Device To Detect Antibodies To Hepatitis D Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGW
Too few SGW 510(k)s in any year since 2007 to give a median.
Recalls per year · SGW
No recall names SGW since 2007.
Adverse event reports per year · SGW
No MAUDE report names SGW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 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 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LIAISON XL MUREX Anti-HDV assay uses chemiluminescence immunoassay (CLIA) technology for the qualitative detection of antibodies to the hepatitis D virus (anti-HDV) in adult human serum, lithium, sodium heparin, and K2-EDTA plasma. The assay is intended as an aid in the presumptive diagnosis of HDV infection in individuals who are HBsAg positive and at risk for HDV infection. Assay results, in conjunction with other laboratory results and clinical…
Read the full statement (157 words)
The LIAISON XL MUREX Anti-HDV assay uses chemiluminescence immunoassay (CLIA) technology for the qualitative detection of antibodies to the hepatitis D virus (anti-HDV) in adult human serum, lithium, sodium heparin, and K2-EDTA plasma. The assay is intended as an aid in the presumptive diagnosis of HDV infection in individuals who are HBsAg positive and at risk for HDV infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide evidence of infection with HDV. This test does not determine the state of infection or associated disease.
The test must be performed on the LIAISON XL Analyzer.
The LIAISON XL MUREX Control Anti-HDV (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON XL MUREX Anti-HDV assay. The performance characteristics of LIAISON XL MUREX Anti-HDV controls have not been established for any other assays or instrument platforms different from LIAISON XL Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250032 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250032: LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250032
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026