(567 days)
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, 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.
The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. 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.
The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer 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. The Piccolo® Potassium Test System is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternatively, the disc may also be used with serum.
The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed.
The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Performance Characteristic | Acceptance Criteria (Implied by CLIA goals or standard practices) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within Run %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 2.79% | |
| - Control 2 (6.19 mmol/L) | 1.38% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.31% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.58% | |
| Total %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 3.28% | |
| - Control 2 (6.19 mmol/L) | 1.65% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.89% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.89% | |
| Total %CV (Whole Blood, range 3.9-4.0 mmol/L) | Lower is better | 2.8% - 3.9% |
| Linearity | Deviation from linearity (DL) within ±0.5 mmol/L (per 42 CFR 493.931) | For all three matrices and various concentration ranges tested, the DL estimate was within +/- 0.31. R-square estimates were all > 0.98. RMSE estimates |
§ 862.1600 Potassium test system.
(a)
Identification. 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 conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.