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510(k) Data Aggregation
(181 days)
The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection.
Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Anti-HAV IgM is used for quality control of the Elecsys Anti-HAV IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Anti-HAV IgM immunoassay utilizes a u-capture test concept based on a monoclonal h-IgM directed biotinylated antibody, cell culture derived Hepatitis A Virus and a ruthenylated monoclonal antibody directed to HAV. Capture of formed immune complexes from the reaction mixture is based on biotin binding to streptavidin-coated magnetic microparticles which are collected on a measuring cell electrode. Signal generation is triggered by the application of a voltage to the electrode (electrochemiluminescence technology). The level of signal count detected by the system increases as the concentration of the IgM antibody target present in a patient sample increases.
The Elecsys PreciControl Anti-HAV IgM contains control serum based on human serum in the negative and positive concentration range. The controls are used for monitoring the accuracy of the Elecsys Anti-HAV IgM immunoassays.
The Elecsys® Anti-HAV IgM immunoassay is intended for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma. The assay is meant to aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection.
Here's an analysis of the acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. However, the study aims to demonstrate the performance of the Elecsys Anti-HAV IgM immunoassay by comparing it to an FDA-cleared reference method. The implicit acceptance criterion is a high level of agreement with the predicate device across various sample cohorts.
| Performance Metric | Implicit Acceptance Criterion (High Agreement) | Reported Device Performance (Overall Cohort) |
|---|---|---|
| Positive Percent Agreement (PPA) | High PPA | 97.5% (118/121) with 95% CI (92.9% - 99.5%) |
| Negative Percent Agreement (NPA) | High NPA | 99.3% (959/966) with 95% CI (98.5% - 99.7%) |
| Analytical Sensitivity: | ||
| Earliest reactive result vs. predicate | Similar or earlier | Matches or earlier on HAV-01 and PHT 902 |
| Last positive result vs. predicate | Similar or later | Varies, generally similar or earlier |
| Precision (CV%) | Low CV% | |
| Elecsys 2010 (Repeatability) | Low (e.g., |
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