# K123586: Easyra Creatinine Reagent

- Pathway: 510(k) (Special)
- Applicant: Medica Corporation
- Decided: May 15, 2013 after 175 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- 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 Creatinine (C REA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K123586
Methodology: https://510kreport.com/methodology