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510(k) Data Aggregation
(60 days)
The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum or plasma. Measurements 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.
Direct Bilirubin is an in vitro diagnostic assay for the quantitative determination of direct bilirubin in human serum or plasma. The Direct Bilirubin assay is a clinical chemistry assay in which the conjugated bilirubin reacts with diazotised sulphanilic acid to produce an acid azobilirubin, the absorbance of which is proportional to the concentration of direct bilirubin in the sample and can be measured at 550 nm.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for the Abbott Laboratories DBil (Alcyon Direct Bilirubin) assay.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate device (Roche Cobas Mira Plus Direct Bilirubin assay) and another established method (Boehringer Mannheim Direct Bilirubin assay on Hitachi 717 analyzer). Specific criteria likely involved correlation coefficients near 1, and slopes and intercepts indicative of good agreement. | Vs. Roche Cobas Mira Plus: Correlation coefficient = 0.997, slope = 0.77, Y-intercept = 0.08 mg/dL. Reported as "acceptable correlation." |
| Vs. Boehringer Mannheim (Hitachi 717): Correlation coefficient = 0.996, slope = 1.08, Y-intercept = -0.03 mg/dL. Reported as "acceptable correlation." | ||
| Precision | Total %CV within acceptable clinical limits for two levels of control material (not explicitly stated, but implied by "acceptable"). | Total %CV (all studies combined): |
| Level 1/Panel 111: ranged from 5.9% to 10.4% | ||
| Level 2/Panel 112: ranged from 2.7% to 3.0% (across within-run, between-run, and between-day studies). | ||
| Linearity | Linear range up to a certain concentration (not explicitly stated, but implied by "linear up to"). | Linear up to 10 mg/dL. |
| Limit of Quantitation (Sensitivity) | Below a clinically relevant threshold (not explicitly stated, but implied by "sensitivity"). | 0.1 mg/dL. |
| Substantial Equivalence | Performance characteristics similar to the predicate device. | "These data demonstrate that the performance of the Direct Bilirubin assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay." The conclusion states, "The Direct Bilirubin assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay as demonstrated by results obtained in the studies." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of patient samples used in the method comparison studies. It mentions "two levels of control material" for precision studies but not the number of replicates or runs.
- Data Provenance: Not specified. It's likely retrospective, given the nature of the method comparison and precision studies often performed in a lab setting, but this is not explicitly stated. The country of origin is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable to this type of device. The ground truth for this device (a quantitative in vitro diagnostic assay) is established by the reference methods themselves (the predicate device and the Boehringer Mannheim assay). No human experts were used to establish a "ground truth" for the test set in the traditional sense of diagnostic imaging or clinical consensus.
4. Adjudication Method for the Test Set
- Not applicable. This is a quantitative chemical assay, not an interpretation-based diagnostic device requiring adjudication of human readings. The "adjudication" is inherent in the numerical results obtained from the reference methods.
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 is an in vitro diagnostic assay, not a device that assists human readers in interpreting images or data. Therefore, an MRMC study and effects on human reader improvement are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, this was a standalone performance study. The entire study focuses on the analytical performance of the DBil assay itself, without any human-in-the-loop component for interpretation or diagnosis. The results directly reflect the algorithm's (assay's) ability to quantify direct bilirubin.
7. The Type of Ground Truth Used
- The "ground truth" for the performance evaluation was established by:
- Predicate Device: The Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay (K910593). This is a previously cleared, legally marketed device.
- Established Method: The Boehringer Mannheim Direct Bilirubin assay on the Hitachi 717 analyzer. This represents another recognized and established method for direct bilirubin measurement.
- Known Concentration Control Materials: For precision studies, "control material" with known or target concentrations would have been used.
8. The Sample Size for the Training Set
- Not applicable. This document describes a traditional chemical assay, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The assay's parameters are based on established chemical principles, not learned from a dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable (as per point 8).
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