(264 days)
The EasyRA DBIL Reagent is for the in vitro measurement of Direct Billirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measwements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block, EasyRA Bilirubin-Total Reagent The EasyRA TBIL Reagent is for the in vitro measurement of Total Bilirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measwements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. The EasyRA Phosphorus Reagent is for the in vitro measurement of phosphorus in serum on the Medica EasyRA analyzer. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance. The EasyRA Iron Reagent is for the in vitro measurement of iron in serum on the Medica EasyRA analyzer. Iron measurements are used in the diagnosis and treatment of iron deficiency anemia, hemochromatosis, and chronic renal disease. The EasyRA Magnesium Reagent is for the in vitro measurement of phosphorus in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.
Not Found
I am sorry, but the provided text only contains a 510(k) clearance letter from the FDA for several EasyRA reagents. It does not include acceptance criteria, performance data from a study, or details about the methodology of such a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC study, or training set information).
Therefore, I cannot provide the requested information based on the input.
§ 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.