# DEN250032: LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)

- Pathway: De Novo (Direct)
- Applicant: DiaSorin, Inc.
- Decided: Dec 23, 2025 after 146 days
- Product code: SGW (Device To Detect Antibodies To Hepatitis D Virus)
- Device class: 2
- Regulation: 21 CFR 866.3176
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN250032
Methodology: https://510kreport.com/methodology