LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM FDA PMA
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA
Identifiers
- PMA Number
- P180045 FDA PMA
- FDA Product Code
- SEI FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3173 FDA PMA
- Regulation Number
- 866.3173 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The LIAISON XL MUREX HBc IgM is a chemiluminescent immunoassay (CLIA) for the qualitative detection of IgM antibodies to hepatitis B virus core antigen (HBc IgM) in human serum and plasma, including separator tubes. It is designed for use on the LIAISON XL Analyzer and aids in diagnosing acute or recent hepatitis B virus (HBV) infection in patients with symptoms or risk factors, based on the presence of anti-HBc IgM. The LIAISON XL MUREX Control HBc IgM serves as a quality control sample to monitor assay performance, available in negative and positive formats.
This device is intended for use in microbiology laboratories and is supplied as a kit for in vitro diagnostic testing. The LIAISON XL MUREX HBc IgM assay is approved for use with human serum and plasma samples from adults and pediatric patients aged 2 to 21 years, collected in lithium heparin, sodium heparin, sodium citrate, or K2 EDTA tubes. The controls are not validated for use with other assays or platforms. The device is regulated under FDA PMA (P180045) and falls under device class II (866.3173)
Frequently asked questions
What is the LIAISON® XL MUREX HBc IgM assay used for in clinical practice?
The LIAISON® XL MUREX HBc IgM assay is a chemiluminescent immunoassay designed to qualitatively detect IgM antibodies to hepatitis B virus core antigen (HBc IgM) in human serum and plasma. It aids in diagnosing acute or recent hepatitis B virus (HBV) infection in patients who exhibit symptoms of hepatitis or are at risk for HBV exposure. The presence of anti-HBc IgM suggests an active or recent infection, but results should always be interpreted alongside other HBV serological markers and clinical information.
What sample types and patient age groups are approved for use with the LIAISON® XL MUREX HBc IgM assay?
The assay is approved for use with human serum and plasma samples collected in lithium heparin, sodium heparin, sodium citrate, or K2 EDTA tubes, including separator tubes. It is validated for both adult and pediatric patients aged 2 to 21 years. The device is not intended for screening blood, plasma, or tissue donors.
How is the LIAISON® XL MUREX HBc IgM kit supplied, and what role do the controls play?
The LIAISON® XL MUREX HBc IgM is supplied as a kit for in vitro diagnostic testing on the LIAISON® XL Analyzer. The kit includes the assay reagents and two types of controls: the LIAISON® XL MUREX Control HBc IgM (negative and positive). These controls are specifically designed to monitor assay performance and ensure the reliability of results when used with the LIAISON® XL MUREX HBc IgM assay. They are not validated for use with other assays or platforms.
Is the LIAISON® XL MUREX HBc IgM assay single-use, and how should it be stored?
The LIAISON® XL MUREX HBc IgM assay is intended for single-use per the typical design of in vitro diagnostic kits. While the data does not explicitly detail storage conditions, chemiluminescent immunoassays like this are generally stored refrigerated (2–8°C) and protected from light until use. Always refer to the manufacturer’s instructions for precise storage guidelines.
What regulatory pathway was followed for the approval of this device, and what class does it fall under?
The LIAISON® XL MUREX HBc IgM and its controls were approved through the FDA’s Premarket Approval (PMA) pathway under PMA number P180045. The device is classified as Class II under FDA regulation 866.3173, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045 ..., PDF Summary of Safety and Effectivness (SSED)Template, Hepatitis Diagnostics Solutions | Immunodiagnostics | Diasorin
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180045 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P180045 24 fields · synced Oct 6, 2026