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Elecsys Anti-HAV II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190428

by Roche Diagnostics

Identifiers

510(k) Number
K190428 FDA 510(k)
FDA Product Code
LOL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3310 FDA 510(k)
Regulation Number
866.3310 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Elecsys Anti-HAV II is an electrochemiluminescence immunoassay (ECLIA) for the in vitro qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (HAV) in human serum and plasma. It is classified as a hepatitis A test (antibody and IgM antibody) and is designed to aid in identifying past or current HAV infection, as well as assessing antibody response in vaccine recipients. The assay targets both IgG and IgM antibodies, enabling comprehensive serological evaluation of HAV exposure.

This device is intended for use on the cobas e 601 immunoassay analyzer and is supplied as a reagent kit for laboratory testing. It is not approved for blood or plasma donor screening. The assay is validated for use in pediatric patients (ages 2 through 21 years) and adults, with compatible sample types including Li-heparin, potassium EDTA, Na-citrate, and Na-heparin plasma. Regulatory clearance under FDA 510(k) K190428 confirms its compliance with microbiology testing standards, adhering to 21 CFR 866.3310 for in vitro diagnostic devices.

Frequently asked questions

What types of samples can the Elecsys Anti-HAV II test, and how should they be prepared for analysis?

The Elecsys Anti-HAV II is designed to detect hepatitis A virus antibodies in human serum and plasma collected with Li-heparin, potassium EDTA, Na-citrate, or Na-heparin anticoagulants. It is validated for use in both pediatric patients (ages 2–21) and adults. No additional sample preparation is required beyond standard centrifugation to separate plasma or serum from whole blood, as the assay is compatible with these pre-processed sample types.

Is the Elecsys Anti-HAV II intended for screening blood or plasma donors, and if not, what is its primary clinical use?

No, the Elecsys Anti-HAV II is not approved for blood or plasma donor screening. Its primary clinical purpose is to aid in identifying past or current hepatitis A virus (HAV) infection by detecting total antibodies (IgG and IgM) in patient samples. It also helps assess antibody response in individuals who have received the HAV vaccine, enabling comprehensive serological evaluation of HAV exposure.

How is the Elecsys Anti-HAV II supplied, and what analyzer does it require for operation?

The Elecsys Anti-HAV II is supplied as a reagent kit for laboratory use. It is exclusively designed to run on the cobas e 601 immunoassay analyzer, an automated platform for electrochemiluminescence immunoassays (ECLIA). The kit includes all necessary components for performing the assay on this specific analyzer.

What regulatory pathway was followed for the Elecsys Anti-HAV II, and what does this mean for its use in clinical settings?

The Elecsys Anti-HAV II received FDA 510(k) clearance (K190428) under the traditional review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This clearance confirms compliance with 21 CFR 866.3310 for in vitro diagnostic devices, ensuring its safety, performance, and effectiveness for detecting HAV antibodies in clinical microbiology settings. Clinicians can rely on this regulatory pathway to validate its use for identifying HAV infection or vaccine response.

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: Elecsys® Anti-HAV II - Roche Diagnostics USA, Elecsys® Anti-HAV II - Roche Diagnostics USA, Elecsys Anti-HAV II - elabdoc-prod.roche.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics

Sources (1)

  • FDA 510(k) K190428 24 fields · synced Sep 20, 2026