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Monolisa Anti-HAV IgM EIA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063319

by Bio-Rad Laboratories

Identifiers

510(k) Number
K063319 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 Monolisa Anti-HAV IgM EIA is an enzyme immunoassay (EIA) for the qualitative detection of IgM antibodies to hepatitis A virus (HAV) in human serum or plasma. It is classified under the device type 'Hepatitis A Test (Antibody and IgM Antibody)' and is designed to identify recent HAV infection by detecting specific IgM antibodies, which appear shortly after exposure and persist for approximately two months.

This device is intended for manual use and is supplied as a diagnostic test kit. It is regulated under FDA 510(k) clearance (K063319) and falls under Class II medical devices. The test requires human serum or plasma samples and is used in microbiology settings for laboratory analysis. No information regarding sterility, single-use, or MRI safety is provided in the specifications.

Frequently asked questions

What clinical purpose does the Monolisa Anti-HAV IgM EIA serve in a laboratory setting?

The Monolisa Anti-HAV IgM EIA is designed to detect IgM antibodies against hepatitis A virus (HAV) in human serum or plasma. These antibodies appear shortly after infection and typically persist for about two months, making this test useful for identifying recent HAV exposure or acute infection in microbiology labs.

How is the Monolisa Anti-HAV IgM EIA supplied, and what type of samples does it require?

The Monolisa Anti-HAV IgM EIA is supplied as a diagnostic test kit intended for manual use in laboratory settings. It requires human serum or plasma samples for analysis, as specified in its intended use.

Is this device intended for single-use or reusable applications, and what are its sterility or safety considerations?

The provided data does not specify whether the Monolisa Anti-HAV IgM EIA is single-use or reusable. Additionally, no information is given regarding sterility or safety considerations like MRI compatibility, so these details would need to be confirmed directly with Bio-Rad Laboratories.

What regulatory pathway was followed for the FDA clearance of this device, and what class does it belong to?

The Monolisa Anti-HAV IgM EIA received FDA clearance through a 510(k) submission (K063319) under the traditional review pathway, with a decision of substantially equivalent (SESE). It is classified as a Class II medical device, regulated under the product code LOL and falls under the Microbiology specialty.

Are there any specific storage or handling instructions mentioned for this test kit?

The provided data does not include storage or handling instructions for the Monolisa Anti-HAV IgM EIA. For proper storage and usage guidelines, refer to the manufacturer’s official documentation or contact Bio-Rad Laboratories directly.

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: MONOLISA Anti-HAV IgM EIA - Bio-Rad, MONOLISA Anti-HAV EIA - Bio-Rad, MONOLISA ANTI-HAV IGM EIA (K092353) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA 510(k) K063319 24 fields · synced Sep 19, 2026