# K070057: Easyra Clinical Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Aug 30, 2007 after 237 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K093357: Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module Calibrant B, Model ME-5410D (2010), 0 descendants of its own

## Recalls of this device
- Mar 29, 2010 · Not classified · Z-0078-2011: Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results. The defect is a shortened pat

## Indications for use
The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na + (sodium), K + (potassium), Cl- (chloride), Li + (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lithium measurements are used to assure that the proper drug dosage is administered in the treatment of patients ith mental disturbances, such as manic-depressive illness (bipolar disorder).

Source page: https://510kreport.com/device/K070057
Methodology: https://510kreport.com/methodology