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Elecsys Anti-HBC IgM Assay (Modular Analytics E170 Analyzer)

FDA PMA

Class II (US FDA PMA)

PMA P110025

by Roche Diagnostics Corp.

Identity

Trade Name
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA FDA PMA
Generic Name
Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA

Identifiers

PMA Number
P110025 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 Elecsys Anti-HBC IgM Assay is an electrochemiluminescence immunoassay (ECLIA) intended for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (Anti-HBC IgM) in human serum or plasma. It is classified under qualitative and quantitative hepatitis B virus antibody assays and is designed for use on the Modular Analytics E170 Immunoassay Analyzer.

This assay is supplied as a reagent kit for laboratory use and is intended for adult patients with symptoms of hepatitis or those at risk for hepatitis B virus (HBV) infection. The presence of Anti-HBC IgM, alongside other laboratory results and clinical information, aids in diagnosing acute or recent HBV infection. The Elecsys Anti-HBC IgM Assay is approved for use under FDA PMA (P110025) and is not intended for monitoring HBV disease or therapy.

Frequently asked questions

What types of patient samples can the Elecsys Anti-HBC IgM Assay analyze, and why is this important for clinical use?

The assay is designed to analyze human serum or plasma collected with potassium EDTA, lithium heparin, sodium heparin, or sodium citrate. This flexibility is important because it allows laboratories to use leftover samples from routine blood draws, reducing the need for additional phlebotomy and improving efficiency in diagnosing acute or recent hepatitis B virus infection.

Is the Elecsys Anti-HBC IgM Assay intended for routine monitoring of hepatitis B disease or treatment, and if not, what is its clinical purpose?

No, the assay is explicitly not intended for monitoring hepatitis B disease progression or therapy. Instead, it is used to qualitatively detect IgM antibodies to hepatitis B core antigen in adult patients with hepatitis symptoms or those at risk for HBV infection. The results, combined with other lab findings and clinical data, help confirm acute or recent HBV infection, aiding in timely diagnosis and management.

How is the Elecsys Anti-HBC IgM Assay supplied, and what equipment is required to run it?

The assay is supplied as a reagent kit for laboratory use. It is designed exclusively for the Modular Analytics E170 Immunoassay Analyzer, an automated platform that performs electrochemiluminescence immunoassays (ECLIA). Laboratories must own or have access to this analyzer to run the test, as the kit is not standalone or compatible with other systems.

What is the regulatory pathway for the Elecsys Anti-HBC IgM Assay, and how does this affect its availability?

The assay holds an FDA Premarket Approval (PMA) under P110025, meaning it has undergone rigorous review to demonstrate safety and effectiveness for its intended use. This regulatory clearance ensures its availability in the U.S. market for qualified laboratories equipped with the required analyzer, though clinicians should confirm local regulatory compliance and institutional access before use.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA PMA P110025 24 fields · synced Oct 6, 2026