FDA 510K for Potassium Test System
A potassium test system measures the amount of potassium in your blood or urine. It can be performed using a blood test or a urine test. Potassium is a vital electrolyte, meaning it carries an electrical charge and plays a critical role in maintaining various functions in the body. These include regulating fluid balance, muscle contractions, nerve signals, and heart function.
Intended Use of Potassium Test System
A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases characterized by low or high blood potassium levels.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Potassium Test System
FDA 510K for Potassium Test System Device Code and Regulation Number
| Sl. No | Product Code | Device | Regulation Description | Regulation Number | Class |
|
1 |
Test, System, Potassium, Enzymatic Method | Potassium Test System |
862.1600 |
2 |
Test, System, Potassium, Enzymatic Method
Intended Use:
It is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
Device Description:
The enzymatic method for potassium testing relies on potassium ions activating specific enzymes, such as potassium-dependent pyruvate kinase. This enzyme catalyzes a reaction that is coupled with other biochemical processes, often producing a measurable signal like a color change or light emission. The intensity of the signal is directly proportional to the potassium concentration in the sample. This signal is then measured using instruments like a spectrophotometer or fluorometer, and the potassium level is determined by comparing the signal to a standard curve. This method is precise due to its reliance on the role of potassium in biological reactions.
Performance Testing (Analytical) for Potassium Test System
- Precision (Reproducibility and Repeatability)
- Accuracy
- Detection Studies
- Sensitivity and Specificity
- Interference
Clinical Testing:
No Guidance available for 510k submission