(78 days)
AuraFlex Ferritin is a fluorescent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System.
Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.
Fluorescent immunoassay reagents.
Here's the analysis of the provided information regarding the AuraFlex® Ferritin device:
Due to the nature of the device (immunoassay for Ferritin), many of the acceptance criteria points (like expert readers, adjudication, MRMC studies) are not applicable as this is not an image-based or human-interpretive diagnostic device. The study described focuses on the analytical performance of the assay.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Correlation with an established predicate device (analytical performance) | 0.99 (AuraFlex® Ferritin = 0.99 Other Ferritin assay + 1.9 ng/ml (ug/1)) |
Study Details
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Sample size used for the test set and the data provenance:
- Sample size: 94 human serum samples.
- Data provenance: Not explicitly stated, but the samples were human serum. The document doesn't specify the country of origin or if it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is an immunoassay, and "ground truth" for its analytical performance is typically established by comparison to a reference method or a predicate device, not by expert interpretation.
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Adjudication method for the test set:
- Not applicable. The "ground truth" was established via a comparative study with another Ferritin assay.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool requiring human interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study performed was a standalone analytical performance study of the AuraFlex® Ferritin assay. It compared the results of the new assay directly against an "Other Ferritin assay" without human-in-the-loop performance measurement.
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The type of ground truth used:
- The "ground truth" for demonstrating substantial equivalence was established by comparison to an "Other Ferritin assay," which implicitly served as the reference or predicate method. This is an analytical comparison rather than a clinical ground truth like pathology or outcome data.
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The sample size for the training set:
- Not applicable. This device is an immunoassay, not a machine learning or AI-driven algorithm that requires a training set in the conventional sense. The "training" here would be related to assay optimization and validation during development, not data-driven model training.
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How the ground truth for the training set was established:
- Not applicable (as per point 7).
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).