# K080810: Easyra Bilirubin Direct and Total Reagent, Phosphorus Inorganic Reagent and Iron and Magnesium Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Dec 10, 2008 after 264 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EasyRA DBIL Reagent is for the in vitro measurement of Direct Bilirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. The EasyRA TBIL Reagent is for the in vitro measurement of Total Bilirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measurements 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 iised 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.

Source page: https://510kreport.com/device/K080810
Methodology: https://510kreport.com/methodology