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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.

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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.

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