# K100187: Easyra Glu-T Reagent, Easyra Glu-H Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: May 5, 2010 after 103 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 Glucose Trinder (GLU-T) Reagent is for the measurement of glucose in serum and plasma using the EasyRA chemistry analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. For in vitro diagnostic use only. The EasyRA Glucose Hexokinase (GLU-H) Reagent is for the measurement of glucose in serum and plasma, using the EasyRA chemistry analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K100187
Methodology: https://510kreport.com/methodology