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510(k) Data Aggregation
(210 days)
The ARCHITECT Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma on the ARCHITECT c8000 system. Measurement of total 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.
A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
ARCHITECT Total Bilirubin is an in vitro diagnostic assay for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates. Total (conjugated and unconjugated) bilirubin couples with the diazo reagent in the presence of a surfactant to form azobilirubin. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration.
This document is a 510(k) summary for the ARCHITECT Total Bilirubin assay. This device is an in vitro diagnostic assay, and therefore the acceptance criteria and study details are focused on analytical performance, not clinical performance based on human reader interpretations.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "correlation coefficient must be > 0.99"). Instead, the document states generally that the method comparison "yielded acceptable correlation" and that the data "demonstrate the performance of the modified ARCHITECT Total Bilirubin assay is substantially equivalent to the performance of Abbott Total Bilirubin assay." The reported device performance metrics are provided.
| Performance Metric Area | Specific Criterion/Test | Intended Outcome (Acceptance Criteria - Implicit) | Reported Device Performance |
|---|---|---|---|
| Method Comparison (Adult Application) | Correlation with original Total Bilirubin assay | Acceptable correlation | Correlation coefficient: 0.9991 |
| Slope: 0.98 | |||
| Y-intercept: 0.07 mg/dL | |||
| Method Comparison (Neonate Application) | Correlation with Roche Total Bilirubin assay | Acceptable correlation | Correlation coefficient: 0.9967 |
| Slope: 0.99 | |||
| Y-intercept: 0.32 mg/dL | |||
| Precision | Total %CV for various levels | Acceptable precision | Level 1: 1.96% |
| Level 2: 1.43% | |||
| Level 3: 1.20% | |||
| Level 4: 1.00% | |||
| Linearity | Linear range | 0.1 to 25.0 mg/dL | |
| Functional Sensitivity (Limit of Quantitation) | < 0.1 mg/dL | ||
| Limit of Detection (LOD) | 0.05 mg/dL |
2. Sample Sizes Used for the Test Set and Data Provenance
- Adult Application Test Set: 138 adult serum samples, ranging from 0.11 to 23.96 mg/dL.
- Neonate Application Test Set: 54 neonate serum samples, ranging from 0.94 to 19.05 mg/dL.
- Data Provenance: The document does not specify the country of origin. The studies appear to be retrospective as they are testing existing samples against established methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of in vitro diagnostic device study. The "ground truth" is established by the results of a predicate or reference device/method (Abbott Total Bilirubin assay or Roche Total Bilirubin assay on Hitachi 717 Analyzer), not by human expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The comparisons are quantitative measurements between devices, not human expert adjudications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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 device, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, this study represents a standalone performance evaluation of the ARCHITECT Total Bilirubin assay. It's evaluating the automated assay's ability to measure total bilirubin.
7. The Type of Ground Truth Used
The "ground truth" (or reference method) used for the test sets was the results obtained from:
- Adult Application: The original Abbott Total Bilirubin assay (K060574).
- Neonate Application: The Roche Total Bilirubin assay on the Hitachi 717 Analyzer.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" in the context of machine learning or AI. For in vitro diagnostic assays, the calibration and optimization (which would be analogous to "training") of the assay's reagents and instrument parameters would have occurred during its development, but the sample size for that process is not detailed here. The described studies are primarily validation/verification testing.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated or applicable as in AI/ML contexts. The "ground truth" for calibrating and developing the assay would typically be established through highly characterized reference materials, pure chemical standards, and potentially reference measurement procedures, all following established laboratory practices for quantitative analytical assays.
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