(34 days)
Not Found
When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the vanadate oxidation.
Here's a breakdown of the acceptance criteria and the study details for the Wako Total Bilirubin V assay, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Correlation with predicate device | Correlation coefficient of 0.997; regression equation y = 1.003x + 0.09 |
| Precision (day-to-day) | Precision studies indicate acceptable values |
| Minimum detectable level | 0.03 mg/dL |
| Linearity | Linear to 40 mg/dL |
| Absence of interference by coexistent substances | Practically no interference by coexistent substances (claimed) |
Study Details
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Sample size used for the test set and the data provenance:
- The document states that "serum samples" were used for comparison studies against the predicate assay. The exact number of samples is not specified.
- The data provenance (country of origin, 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 applicable as the study compares a new device to a predicate device, not against a clinical expert's interpretation. The "ground truth" for the test set is established by the results from the predicate device (Wako's previous Total Bilirubin assay, K912024/A).
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Adjudication method for the test set:
- Not applicable. This is a comparison of quantitative measurements between two devices, not a qualitative assessment requiring adjudication of human interpretations.
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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. This is a study comparing two laboratory diagnostic devices for bilirubin measurement, not a study involving human readers or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. This study describes the performance of a standalone laboratory assay (Wako Total Bilirubin V) in comparison to another standalone laboratory assay (the predicate device). There is no "human-in-the-loop" component in the direct measurement process being evaluated.
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The type of ground truth used:
- The "ground truth" for the comparative study was the results obtained from the predicate device (Wako's previous Total Bilirubin assay, 510(k)#K912024/A).
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The sample size for the training set:
- This concept is not applicable to this type of device and study. The Wako Total Bilirubin V assay is a chemical measurement method; it does not involve machine learning algorithms that require a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.