(18 days)
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurements of the levels of 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.
Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of Total Bilirubin in human serum or plasma. The Total Bilirubin assay is a clinical chemistry assay in which the analyte in the sample reacts with diazotised sulphanilic acid to produce an acid azobilirubin, the absorbance of which is proportional to the concentration of bilirubin in the sample.
The information provided describes the performance of the Abbott Laboratories TBil (Total Bilirubin) assay. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" with predefined thresholds for each performance characteristic. Instead, it demonstrates substantial equivalence to a predicate device (Roche® Cobas Mira® Plus Automated Chemistry System Total Bilirubin assay) by showing comparable performance. The reported performance metrics are presented below:
| Performance Characteristic | Reported Device Performance (TBil Assay) | Equivalence Justification/Predicate Performance |
|---|---|---|
| Correlation with Predicate | Correlation coefficient = 0.9925 | Substantially equivalent to Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay, indicating similar clinical results. |
| Method Comparison (Slope) | Slope = 0.873 | Part of the method comparison with the predicate device, contributing to the demonstration of substantial equivalence. |
| Method Comparison (Y-intercept) | Y-intercept = - 0.072 mg/dL | Part of the method comparison with the predicate device, contributing to the demonstration of substantial equivalence. |
| Precision (Within-run, %CV) | Not explicitly stated separately, but included in total %CV. | Studies were conducted using two levels of control material. |
| Precision (Between-run, %CV) | Not explicitly stated separately, but included in total %CV. | Studies were conducted using two levels of control material. |
| Precision (Between-day, %CV) | Not explicitly stated separately, but included in total %CV. | Studies were conducted using two levels of control material. |
| Precision (Total %CV, Level 1/Panel 111) | 4.8% | Considered acceptable. |
| Precision (Total %CV, Level 2/Panel 112) | 5.1% | Considered acceptable. |
| Linearity (Upper Limit) | 20.0 mg/dL | Considered acceptable for the intended use. |
| Limit of Quantitation (Sensitivity) | 0.264 mg/dL | Considered acceptable for the intended use. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the comparative performance studies (method comparison and precision studies). It mentions that "comparative performance studies were conducted using the ALCYON™ Analyzer" and "precision studies were conducted using the Total Bilirubin assay... using two levels of control material."
- Sample Size: Not explicitly stated for specific studies.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the study focuses on the analytical performance of the device in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not relevant or provided for this device. The device is an in vitro diagnostic assay for quantitative determination of a chemical analyte (Total Bilirubin). The ground truth for such devices is established by comparing the device's measurements to a reference method or validated predicate device, not by expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As mentioned above, this is an in vitro diagnostic assay, not a subjective diagnostic interpretation. The comparison is objective, based on measured values and statistical correlation.
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
Not applicable. This device is an automated in vitro diagnostic assay for chemical analysis, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The studies described are of the device's standalone analytical performance. The "comparative performance studies" and "precision studies" evaluate the assay itself, operating as an algorithm within the ALCYON™ Analyzer, comparing its output to a predicate device and assessing its inherent variability and limits. There is no human-in-the-loop component in the direct measurement and quantification of bilirubin by the device.
7. The Type of Ground Truth Used
The "ground truth" for this in vitro diagnostic assay is implicitly the measurements obtained from the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay (K910591), which served as the predicate device. The performance of the new device (TBil) was compared against this established method.
8. The Sample Size for the Training Set
Not applicable/provided. This device is a traditional chemical assay, not a machine learning or AI algorithm that requires a "training set" in the computational learning sense. The assay's parameters would have been developed and optimized based on chemical principles and validation studies, not through a data-driven training process as typically understood for AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, there is no "training set" in the context of this traditional in vitro diagnostic assay.
§ 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.