The bilirubin test is commonly used to assess bilirubin levels in neonates (newborns) to evaluate liver function and detect jaundice. In newborns, bilirubin levels can rise, which can be a sign of jaundice. The test typically measures total bilirubin and unbound (or unconjugated) bilirubin levels

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).

Intended use: It is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial whole-blood

Device description: The bilirubin test is commonly used to assess bilirubin levels in neonates (newborns) to evaluate liver function and detect jaundice. In newborns, bilirubin levels can rise, which can be a sign of jaundice. The test typically measures total bilirubin and unbound (or unconjugated) bilirubin levels.

Total Bilirubin:

• This is the sum of both unbound (unconjugated) bilirubin and bound (conjugated) bilirubin.
• It provides an overall picture of bilirubin metabolism and is used to assess whether the newborn’s liver is processing bilirubin efficiently.

Unbound (Unconjugated) Bilirubin:

• This type of bilirubin has not yet undergone conjugation in the liver and is typically the form that leads to jaundice if levels rise too high.
• It is not water-soluble and is bound to albumin in the bloodstream to be transported to the liver, where it undergoes processing.

• Precision,
• linearity,
• detection limits
• analytical specificity

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking