Atellica CH Diazo Total Bilirubin (D_TBil)

The Atellica CH Diazo Total Bilirubin assay is an in vitro diagnostic test that quantitatively measures total bilirubin in human serum and plasma from adults and neonates using the Atellica CH Analyzer. It is used to diagnose and treat liver, hemolytic, hematological, and metabolic disorders, and in newborn infants to indicate risk of bilirubin encephalopathy (kernicterus).

The candidate device uses a diazo colorimetric method with 2,4-dichloroaniline (DCA) to form a red azocompound proportional to bilirubin concentration, measured photometrically. It has a measuring interval of 0.10–25.00 mg/dL and neonatal reference intervals of <8.00 mg/dL (0–1 day), <12.00 mg/dL (1–2 days), and <16.00 mg/dL (3–5 days). The assay is standardized to NIST Standard Reference Material 916 with detection limits of LoB 0.01 mg/dL, LoD 0.02 mg/dL, and LoQ 0.10 mg/dL.

The submission cites CLSI standards: EP07 (Interference Testing in Clinical Chemistry), EP09-A3 (Measurement Procedure Comparison and Bias Estimation Using Patient Samples), and EP28-A3c (Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory).

Substantial equivalence is demonstrated through method comparison showing excellent correlation (r=0.997) against the predicate Roche Cobas C Total Bilirubin Gen. 3 with regression equation y=1.06x−0.02 mg/dL across 124 samples (0.10–21.81 mg/dL). Both devices use the same diazo colorimetric principle, accept similar sample types (human serum and plasma), and have comparable analytical performance, reference intervals, and clinical applications for adults and neonates.