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The StatChem Stat K is a device intended to measure potassium in anticoagulated venous whole blood. Measurements produced by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. The Stat K may be used for adult or pediatric venous whole blood samples. It may be used by a central laboratory or at point of care sites.

Stat K In Vitro Diagnostic Test System is a medical device used for the in vitro diagnostic measurement of Potassium in venous whole blood. The device consists of a battery operated hand-held Analyzer and a precalibrated and disposable Sensor cartridge. While basically a standard electrochemical device that employs a sensing membrane embedded with the potassium selected ligand Valinomycin, Stat K differs from other similar devices in several important ways. The Sensor cartridge is liquid-free allowing storage at room temperature for several months without degradation of performance. The Sensor cartridge is precalibrated at the factory thus requiring no operator interaction to perform calibration. The Sensor cartridge is designed for single use only. This device is exceptionally simple to use as the operator is required to perform four elementary steps to complete the test; (1) Insert Sensor Cartridge, (2) Peel Sensor cap when prompted, (3) Apply blood sample when prompted, and, (4) Read results on LCD display. The Stat K Potassium Sensor uses an ion selective membrane to determine the concentration of potassium ions in solution. The physical structure of the potassium selective Valinomycin membrane is such that the complexing sites on the membrane selectively bind to the Potassium ion. When complexing occurs, an electrical potential is generated proportional to the logarithm of the potassium ion concentration in the sample. The concentration of Potassium ion is calculated from the electrode potential by use of the Nernst Equation. Calibration of the Stat K In Vitro Diagnostic Test System is automatically performed immediately prior to each potassium determination. Each Potassium Sensor contains a calibration material with a predetermined concentration of Potassium.