Potassium (K+) electrode IVD

A potassium (K+) electrode IVD is an electrochemical sensor designed to measure the concentration of potassium ions in clinical specimens such as blood, serum, or plasma. It works by detecting the electrical potential generated by potassium ions relative to a reference electrode, enabling accurate quantification for diagnostic purposes.

Devices in this category are in vitro diagnostic tools used in clinical laboratories and point-of-care settings to support the assessment of electrolyte balance, kidney function, and metabolic status. They are regulated as medical devices based on their intended use and performance characteristics, with classification and conformity assessment determined by applicable regulatory frameworks in each jurisdiction.