# K110675: Easyra Urea Nitrogen and Creatinine Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Apr 21, 2011 after 42 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- 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. The FDA summary names no predicate by number.

## Indications for use
EasvRA BUN Reagent: The EasyRA Urea Nitrogen (BUN) Reagent is for the measurement of urea nitrogen in serum and plasma using the "EasyRA chemistry analyzer". Urea measurements are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only. EasvRA CREA Reagent: The EasyRA Creatinine (CREA) 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/K110675
Methodology: https://510kreport.com/methodology