# K080874: Easyra Alb Reagent and Easyra Alp Reagent, Model 10218/10214, Easyra Ast Reagent, Model 10206, Easyra CO2 Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Feb 20, 2009 after 326 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- 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 Albumin (ALB) reagent is intended for the quantitative determination of Albumin in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The EasyRA Alkaline Phosphatase (ALP) reagent is intended for the quantitative determination of Alkaline Phosphatase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Alkaline Phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Aspartate Aminotranferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. The EasyRA Carbon Dioxide (CO2) reagent is intended for the quantitative measurement of Carbon Dioxide (CO2) in human serum. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Carbon Dioxide calibrator establishes points of reference that are used in the determination of values in the measurement of Bicarbonate/Carbon dioxide on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's C02 reagent. The EasyRA CREA reagent is a device intended to measure creatinine levels in serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The EasyRA CK reagent is a device intended to measure creatinine kinase activity in serum. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Source page: https://510kreport.com/device/K080874
Methodology: https://510kreport.com/methodology