(45 days)
For the quantitative determination of Total Bilirubin in serum. For IN VITRO diagnostic use. Bilirubin is a bile pigment normally found in serum as a result of red cell destruction. It is a product of hemoglobin breakdown by the reticuloendothetial system and exists in two forms. Unconjugated (indirect) bilirubin is transported to the liver bound by albumin where it becomes conjugated (direct) with glucuronic acid and excreted.
The elevation of total serum bilirubin may occur due to hemolytic processes, liver disease, or a disorder of the biliary tract.
Traditional methods of measuring bilirubin are based on the reaction of bilirubin with a diazo reagent to form the colored compound: azo-bilirubin. The diazo reaction can be accelerated by the addition of various chemicals. For example, Malloy-Evelyn (1) used ethanol, Jendrassik-Grof (2) used caffeine, and Walters-Gerarde (3) used DMSO. Modifications of these methods included the addition of surfactants as solubilizing agents (4). In this method, a 2,4-dichlorophenyl diazonium salt is used as the diazo reagent and the reaction is facilitated by the use of a surfactant.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Bilirubin-SL (TOTAL) Assay." This document is a regulatory communication and does not contain the specific information required to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The letter confirms the device's substantial equivalence to previously marketed devices and outlines regulatory obligations, but it does not include performance study data.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. 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 distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.