MONOLISA Anti-HAV IgM EIA EVOLIS Automated Microplate System 510(k) Decision Summary

About this manual

The document describes the MONOLISA Anti-HAV IgM EIA, an in vitro enzyme immunoassay kit intended for the qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV) in human serum or plasma. It details the regulatory submission for a new indication involving the use of this assay with the EVOLIS Automated Microplate System.

What's inside

• 510(k) Number
• Intended Use
• Device Description
• Substantial Equivalence Information
• Test Principle
• Performance Characteristics

Frequently asked questions

What types of human specimens are acceptable for this test?

The test is intended for use in human serum or plasma collected in EDTA, Heparin, Citrate, or ACD tubes.

What is the required incubation time and temperature for the assay?

The assay requires a plate incubation of 60 ± 5 minutes at 37°C + 2°C.

How much wash solution is needed per well during the wash cycles?

The procedure requires washing each well with at least 370 μL of Working Wash Solution.