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Elecsys Anti-HCV Immunoassay for Use on Cobas E 411

FDA PMA

Class II (US FDA PMA)

PMA P090007

by Roche Diagnostics Corp.

Identity

Trade Name
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER FDA PMA
Generic Name
Assay, enzyme linked immunosorbent, hepatitis c virus FDA PMA

Identifiers

PMA Number
P090007 FDA PMA
FDA Product Code
MZO FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 866.3169 FDA PMA
Regulation Number
866.3169 FDA PMA
Advisory Committee
Microbiology FDA PMA
FDA Decision
APRL FDA PMA

The Elecsys Anti-HCV Immunoassay is an in vitro diagnostic test classified as an enzyme-linked immunosorbent assay for the qualitative detection of total antibodies to hepatitis C virus (anti-HCV) in human serum or plasma (potassium EDTA, lithium heparin, and sodium heparin). It employs electrochemiluminescence immunoassay (ECLIA) technology to identify anti-HCV antibodies, aiding in the presumptive diagnosis of hepatitis C infection in symptomatic individuals or those at risk when used alongside clinical information and other laboratory results. The test does not determine infection status or associated disease.

This assay is designed for use exclusively on the Cobas E411 Immunoassay Analyzer and is supplied as a ready-to-use reagent system. It is intended for laboratory use only and requires adherence to standard in vitro diagnostic procedures. The Elecsys Anti-HCV Immunoassay holds FDA Premarket Approval (PMA) under PMA number P090007, with regulatory classification under device code MZO. Sterility and single-use specifications are not applicable as the assay components are intended for controlled laboratory use within their expiration dates.

Frequently asked questions

What clinical scenarios is the Elecsys Anti-HCV Immunoassay intended to support in patient testing?

The Elecsys Anti-HCV Immunoassay is designed to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection when used alongside clinical information and other laboratory results. It is specifically intended for individuals who exhibit signs or symptoms of hepatitis and for those at risk of HCV infection, such as individuals with potential exposure through blood transfusions, intravenous drug use, or medical procedures. The test detects total antibodies to HCV in human serum or plasma but does not determine infection status or associated disease severity.

How is the Elecsys Anti-HCV Immunoassay supplied, and what equipment is required to run it?

The Elecsys Anti-HCV Immunoassay is supplied as a ready-to-use reagent system exclusively for use on the Cobas E411 Immunoassay Analyzer. It is intended for laboratory use only and does not require additional preparation beyond standard in vitro diagnostic procedures. The assay leverages electrochemiluminescence immunoassay (ECLIA) technology for detection.

Can this assay be used with different types of blood collection tubes, and if so, which ones are compatible?

Yes, the Elecsys Anti-HCV Immunoassay is compatible with human serum or plasma collected in tubes containing potassium EDTA, lithium heparin, or sodium heparin. The assay is designed to detect anti-HCV antibodies in these sample types, ensuring flexibility for routine clinical testing.

Is the Elecsys Anti-HCV Immunoassay intended for single-use or repeated use, and how should it be handled?

The assay components are not designed for single-use or reuse in the traditional sense. Instead, they are supplied as a controlled reagent system for laboratory use within their expiration dates. The Cobas E411 Immunoassay Analyzer processes individual patient samples, and the assay itself is not physically reused—rather, it relies on the analyzer’s automated workflow for consistent, repeatable testing across multiple samples.

What regulatory pathway was followed for FDA clearance of this assay, and what does that mean for its use in clinical settings?

The Elecsys Anti-HCV Immunoassay received FDA Premarket Approval (PMA) under PMA number P090007, indicating a rigorous review process for high-risk medical devices. This approval confirms the assay’s safety, effectiveness, and compliance with FDA standards for detecting anti-HCV antibodies in serum or plasma. Clinicians and laboratories can rely on this regulatory clearance when integrating the test into diagnostic workflows for hepatitis C screening.

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 P090007 24 fields · synced Oct 6, 2026