# K260770: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jun 4, 2026 after 87 days
- Product code: LOM (Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen))
- Device class: 2
- Regulation: 21 CFR 866.3172
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P890014 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P190017: LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test, DiaSorin, Inc. (2020) Summary page 6.
- K141116: Liaison XL Analyzer, DiaSorin, Inc. (2014) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K260770
Methodology: https://510kreport.com/methodology