# K101947: IVD-GE02

- Pathway: 510(k) (Traditional)
- Applicant: Sphere Medical, Ltd.
- Decided: Mar 16, 2011 after 247 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
Longest line of descent: 1 generation back to K934907 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934907: 860 Measurment System, Ciba Corning Diagnostics Corp. (1994) Summary page 2.

## Indications for use
The JVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of PH, PCO 2 , P02, potassium and glucose. pH, PCO2, P02: Measurement of blood gases (PCO 2 , PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Potassium: Measurement of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by high or low potassium levels. Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathetic hypoglycaemnia and of pancreatic islet cell carcinoma. IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO2, p02, potassium and glucose.

Source page: https://510kreport.com/device/K101947
Methodology: https://510kreport.com/methodology