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510(k) Data Aggregation
(86 days)
The MONOLISA™ Anti-HAV IgM EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD). This assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results, in conjunction with other serological or clinical information, may be used for the laboratory diagnosis of individuals with acute or recent hepatitis A. The MONOLISA™ Anti-HAV IgM EIA is intended for manual use and with the Evolis™ Automated Microplate System in the detection of IgM antibodies to hepatitis A virus.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, and cord blood or neonatal specimens.
Warning: This assay is not intended for screening blood or solid or soft tissue donors.
The MONOLISA™ Anti-HAV IgM EIA is an enzyme immunoassay (IgM antibody capture format) for the detection of IgM antibodies to hepatitis A virus. In the assay procedure, patient specimens, a calibrator, and controls are incubated with antibodies coated on the microwells. If IgM antibodies to HAV are present in a specimen or control, they bind to the antibody. Excess sample is removed by a wash step. The HAV Viral Antigen and the Conjugate (containing horseradish peroxidase - labeled mouse monoclonal antibody to HAV) are successively added to the microwells and allowed to incubate. The presence of anti-HAV IgM in the sample enables the HAV Viral Antigen and the Conjugate to bind to the solid phase. Excess Conjugate and HAV Viral Antigen are removed by a wash step, and a TMB Chromogen /Substrate solution is added to the microwells and allowed to incubate. If a sample contains anti-HAV IgM, the bound enzyme (HRP) causes the colorless tetramethylbenzidine (TMB) in the Chromogen solution to change to blue. The blue color turns yellow after the addition of a Stopping Solution. If a sample does not contain anti-HAV IgM, the Chromogen/Substrate solution in the well remains colorless during the substrate incubation, and after the Stopping Solution. The color intensity is measured spectrophotometrically. Absorbance value readings for patient specimens are compared to the cutoff value.
The performance of the MONOLISA™ Anti-HAV IgM EIA was evaluated in conjunction with the EVOLIS™ Automated Microplate System. The EVOLIS™ Automated Microplate System is a fully automated microplate analyzer that performs all functions necessary for the complete processing of microplate assays. Functions include: barcode scanning, sample pre-dilutions, sample and reagent dispensing, plate incubations, plate wash cycles, photometric measurement of completed assay plates and results evaluation. The analyzer instrument is controlled via the EVOLIS™ software, a Windows® 2000 application running on a separate dedicated PC. An operator loads the appropriate microplates, assay reagents, and patient and control samples, then selects assay parameters, loads sample information, initiates instrument processing, and generates result reports.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance (MONOLISA™ Anti-HAV IgM EIA on EVOLIS™ vs. Manual) |
|---|---|---|
| Correlation/Method Comparison | Overall Agreement: High percentage agreement with the manual method. | Overall Percent Agreement: 99.7% (with 95% CI of 98.9 - 99.9%) |
| Positive Agreement: High percentage agreement for reactive samples. | Positive Percent Agreement: 100% (with 95% CI of 96.1 - 100%) | |
| Negative Agreement: High percentage agreement for nonreactive samples. | Negative Percent Agreement: 99.7% (with 95% CI of 98.8 - 99.9%) | |
| Reproducibility (Combination Plate) | Overall Agreement: High percentage agreement with the manual method (individual plate format). | Overall Percent Agreement: 99.4% (with 95% CI of 97.7 - 99.8%) |
| Positive Agreement: High percentage agreement for reactive samples (combination plate). | Positive Percent Agreement: 100% (with 95% CI of 92.7 - 100%) | |
| Negative Agreement: High percentage agreement for nonreactive samples (combination plate). | Negative Percent Agreement: 99.2% (with 95% CI of 97.3 - 99.8%) | |
| Precision | Low coefficients of variation (%CV) for within-run, between-run, between-day variability across different panel members (positive, high negative, negative, and controls), and different sample types (serum, various plasma types). | Within-run %CV: Ranged from 1.3% to 6.1% (Panel Set 1, 2, 3) |
| Between-Run %CV: Ranged from 3.5% to 14.9% | ||
| Between-Day %CV: Ranged from 4.4% to 14.7% | ||
| Total %CV: Ranged from 6.8% to 21.8% | ||
| Reproducibility (Multi-site) | Low coefficients of variation (%CV) for within-run, between-day, between-site, and total variance across different panel members. | Within-run %CV: Ranged from 2.3% to 20.5% (across all sites and panel members) |
| Between-Day %CV: Ranged from 0.4% to 19.4% | ||
| Between-Site %CV: Ranged from 0.0% to 2.9% (for P2 and P5 only, others 0.0%) | ||
| Total %CV: Ranged from 2.5% to 23.9% | ||
| Pipettor and Washer Carry-over | No significant carry-over between samples/wells. | Verified that disposable tip pipettes and washer do not carry residuals. |
| Pipetting Accuracy | Achieve a coefficient of variation (CV) of ≤7.7% across the microwell plate for sample and reagent dispensing. | Demonstrated pipetting accuracy with a CV of ≤7.7%. |
2. Sample Sizes and Data Provenance
- Test set for Correlation/Method Comparison:
- Study 1 (EVOLIS™ vs. Manual): 691 retrospective samples.
- Study 2 (EVOLIS™ Combination Plate vs. Manual): 313 samples.
- Data Provenance: The document does not explicitly state the country of origin. The samples were retrospective.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of experts to establish ground truth for the test set.
- The "ground truth" for the comparison studies was the result of the MONOLISA™ Anti-HAV IgM EIA tested manually (the predicate device). The assumption is that the manual method itself, having received prior FDA clearance (K063319), represents the established truth for HAV IgM detection.
4. Adjudication Method
- The document does not describe a specific adjudication method using experts.
- For borderline results in the correlation studies, the following rule was applied: "specimens that were borderline with the reference assay and negative with EVOLIS™ were considered as false negative for the EVOLIS™." This represents a specific rule for handling discordant borderline results rather than an expert adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- This study pertains to the performance of an automated assay system compared to a manual assay method, not a comparison of human readers with and without AI assistance. Therefore, there is no effect size reported for human readers improving with AI.
6. Standalone Performance Study
- Yes, a standalone (algorithm only) performance study was effectively done. The performance studies (correlation/method comparison, precision, reproducibility, carry-over, pipetting accuracy) evaluate the MONOLISA™ Anti-HAV IgM EIA when used with the EVOLIS™ Automated Microplate System as a fully automated system, without direct human intervention in the result determination process itself (beyond loading, selecting parameters, and generating reports). The "algorithm" here refers to the automated system and its integrated processes compared to the manual method.
7. Type of Ground Truth Used
- The ground truth used for the performance comparison studies was the result from the predicate device (Manual MONOLISA™ Anti-HAV IgM EIA assay). This is a comparative ground truth established by another existing, cleared diagnostic method, rather than direct pathology, expert consensus on clinical findings, or outcomes data.
8. Sample Size for the Training Set
- The document does not specify a separate "training set" in the context of an algorithm or AI model development. This submittal is for an automated system running an existing assay, not a novel AI algorithm that requires training on a data set. Therefore, this information is not applicable or provided.
9. How Ground Truth for Training Set Was Established
- As noted above, there is no explicit "training set" for an AI algorithm mentioned. The performance characteristics of the assay itself (MONOLISA™ Anti-HAV IgM EIA) were established through its prior 510(k) clearance (K063319) when used manually. The current submission focuses on demonstrating that combining this assay with the EVOLIS™ Automated Microplate System yields equivalent performance.
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