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The Atellica® CH Diazo Direct Bilirubin (D DBil) assay is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma using the Atellica® CH Analyzer. Measurement of direct bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic-hematological, and metabolic disorders, including hepatitis and gall bladder block.

Atellica® CH Diazo Direct Bilirubin is a Photometric test using 2,4-dichloroaniline (DCA). Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a red colored azocompound in acidic solution. Absorbance is measured at 545/658 nm.

The provided text describes the performance characteristics and acceptance criteria for the Atellica® CH Diazo Direct Bilirubin (D DBil) assay. Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Note: Specific acceptance criteria for precision and reproducibility are not explicitly listed as single values but are implied by the comprehensive presentation of the data, demonstrating acceptable variability for a diagnostic assay. The document states that the results "support that the Candidate Device... is substantially equivalent."

2. Sample size used for the test set and the data provenance:

• Assay Comparison: N = 100 samples
• Specimen Equivalency (Plasma vs. Serum): N = 53 samples for each plasma type (Lithium heparin, Sodium heparin, K2(EDTA)).
• Precision: N = 80 for each serum level (4 serum levels tested, total 320 measurements).
• Reproducibility: N = 225 for each serum level (4 serum levels tested, total 900 measurements).
• Interferences (HIL and Non-interfering Substances): The number of samples for interference testing is not explicitly stated as a single 'N' for the test set. However, the tables indicate specific analyte concentrations tested (e.g., for Hemoglobin, Lipemia, Acetaminophen, etc.), implying multiple measurements were performed for each interference level.

Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective.

3. 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 device is an in vitro diagnostic assay for quantitative determination of direct bilirubin. The "ground truth" in this context refers to the measured concentration of direct bilirubin, which is established by established laboratory methods, standard reference materials, and comparison to a predicate device, rather than expert interpretation of images or clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., medical imaging interpretation) where multiple readers assess cases and discrepancies are resolved by a super-reader. For a quantitative diagnostic assay, the "ground truth" is determined by objective measurement rather than expert consensus on subjective findings.

5. 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:

This information is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a standalone in vitro diagnostic assay. Its performance is measured independently of human interpretation in the clinical setting, although laboratory personnel operate the analyzer and interpret the numerical results in the context of a patient's overall clinical picture. The studies described (Precision, Reproducibility, Assay Comparison, Specimen Equivalency, Interferences) all reflect the standalone performance of the assay on the Atellica CH Analyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance studies is established by:

• Reference Methods/Predicate Device: The "Assay Comparison" section uses the Wako Direct Bilirubin V assay as the comparative method.
• Internal Reference Standards: The assay's traceability is to internal reference standards manufactured by gravimetric methods.
• Control Samples/Spiking: For precision, reproducibility, and interference studies, samples are prepared with known concentrations of analyte or interferents.

8. The sample size for the training set:

This information is not provided in the document. This type of detail is typically associated with machine learning or AI algorithm development, which is not the primary focus of this in vitro diagnostic device submission. The device involves a chemical reaction and photometric measurement, not a "training set" in the machine learning sense.

9. How the ground truth for the training set was established:

This information is not provided and is not applicable as the device does not involve a "training set" in the context of machine learning. The assay mechanism is based on a defined chemical reaction (diazo colorimetry) rather than a trained algorithm.

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