(57 days)
The Wako IgA II -- HA test is an in vitro assay for the quantitative determination of immunoglobulin A in serum.
The Wako IgA II-HA test is a highly specific reagent based on turbidimetric immunoassay. When a sample is mixed with the Buffer solution and Anti-IgA, IgA in the sample combines specifically with anti-human IgA antibody in the Anti-IgA to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgA in the sample.
Here's an analysis of the provided text to extract the requested information about acceptance criteria and the device study:
Device: Wako IgA II-HA test (for quantitative determination of immunoglobulin A in serum)
Acceptance Criteria and Device Performance
The provided documentation does not explicitly state pre-defined "acceptance criteria" in the format of a threshold that the device needed to meet. Instead, the safety and effectiveness are established through substantial equivalency to a predicate device (Wako IgA HA-Direct product). The performance metrics reported are primarily comparative.
Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria are not presented, the table below reflects how the device performance was compared to its predicate to establish substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Wako IgA II-HA vs. Wako IgA HA-Direct) |
|---|---|---|
| Correlation Coefficient | High correlation to predicate device | 0.994 |
| Regression Equation | Relationship to predicate device indicating similar measurement | y = 1.227x - 63.64 |
| Precision | Acceptable values on a day-to-day basis | "Precision studies indicate acceptable values can be obtained on a day to day basis." (Specific metrics not provided) |
| Minimum Detectable Level | Not explicitly stated as a comparative criterion, but a performance characteristic. | 15 mg/dL |
| Intended Use | Identical to predicate device | Used to measure IgA in serum |
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size for the comparison study.
- The country of origin for the data is not specified.
- The study type (retrospective or prospective) is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The comparison is against a predicate device, which implies the predicate's measurements serve as a reference, but it doesn't detail how the "ground truth" for the predicate itself was established in this context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This type of adjudication method is not applicable as the study described is a comparison of two quantitative analytical devices, not an interpretive task often subject to expert adjudication.
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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:
- No, an MRMC comparative effectiveness study was not conducted. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting results.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance evaluated is that of the device algorithm (turbidimetric immunoassay) in a standalone manner, as it quantitatively determines IgA in serum. Human intervention is involved in operating the device and collecting samples, but the core measurement and comparison are algorithm-driven.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is implicitly the measurements obtained from the predicate device, Wako IgA HA-Direct product. The study demonstrates the correlation and regression of the new device's measurements against those of the legally marketed predicate. This is a common approach for establishing substantial equivalence for IVDs.
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The sample size for the training set:
- The concept of a "training set" is not applicable here as this is a traditional in-vitro diagnostic assay validation, not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of a machine learning model.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).