A bilirubin test measures the level of bilirubin in the blood, a substance produced when the liver breaks down red blood cells. The test can measure total bilirubin, which includes both direct (conjugated) and indirect (unconjugated) bilirubin, or direct bilirubin, which specifically measures the conjugated form processed by the liver. Elevated bilirubin levels may indicate liver disease, bile duct obstruction, or excessive red blood cell breakdown (hemolysis)

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 distribution of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Intended use: It is used in the quantitative determination of direct bilirubin in human serum and plasma. Measurement of direct 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.

Device Description: Diazo colorimetry is a method used to measure bilirubin levels in blood samples by reacting bilirubin with a diazo reagent, typically diazotized sulfamic acid, which forms a colored complex. The intensity of the color produced is proportional to the concentration of bilirubin and is measured using a spectrophotometer. This technique helps determine total, direct (conjugated), and indirect (unconjugated) bilirubin levels. It’s commonly used for diagnosing conditions like jaundice, liver disease, and hemolysis. While fast and effective, it can be influenced by factors like hemolysis or lipemia, which may cause interference in the results.

• Detection of limit
• Precision
• Reproducibility
• Assay comparison
• Analytical Specificity

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking