(592 days)
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technical laboratories to aid in the dagnosis and treatment of patients with electrolyte and/or acid-base disturbances.
Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Calcium (Ca++) (ionized) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The EasyStat 300 is a system for use by health care professionalsto rapidly analyze venous and arterial whole blood samples in a clinical laboratory setting. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor, used in the calculation of the patient sample.
The analyzer employs "Ion Selective Electrode" (ISE) sensors for K*, Ca**, Cl¯.
The EasyStat 300 uses 175µL of whole blood in the "Syringe" mode to analyze patient samples. The EasyStat 300 reports results for Potassium (K+), Calcium (Ca++), Chloride (Cl-). Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual.
Medica's EasyQC materials (REF 8315/8316/8317) are specifically formulated for the EasyStat 300. Medica requires the use of quality controls every day patient samples are analyzed and after any troubleshooting is performed, as instructed in the Operator's Manual, to validate the performance of the analyzer. The analyzer stores QC results and provides a statistical analysis of its performance using Levey-Jennings plots for the last 30 consecutive days.
The Reagent Module (REF 8101) has a twelve-month shelf-life when stored at 4º-25ºC.
The electrolyte sensors (K, Ca, Cl) have one-year shelf-life when stored at 4º-25ºC. Use-Life of the sensors is determined from their calibration profiles and from the reported results during the EasyQC analysis. Sensors are replaced by the operator as described in the Operator's Manual. An automatic calibration is performed after installation to qualify the new sensor(s) and the operator is instructed to use the EasyQC multi-level QC materials to validate the EasyStat 300 performance.
The EasyStat 300 may be equipped with a Medica provided barcode scanner (REF 8420) via a USB port to automatically enter patient sample and EasyQC material information. Details are provided in the operator's Manual.
To maintain the performance of the analyzer Medica provides a cleaning solution (REF 8305) and a troubleshooting kit (REF 8250). Their proper uses are described also in the operator's Manual.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance studies (Precision, Linearity, Method Comparison, Sensitivity, Selectivity) and lists specifications or desired outcomes that serve as acceptance criteria. The actual performance is described within each study's results.
Note: The document does not explicitly present a "table of acceptance criteria and reported device performance" as a single, consolidated table. I will construct it based on the details provided in different sections.
| Study Type | Analyte | Acceptance Criteria / Performance Specification | Reported Device Performance (Summary from text) |
|---|---|---|---|
| 20-Day Precision (Aqueous Controls) | Cl- (Repeatability) | Level 1: SD 2.0 | Level 1: SD ~0.04-0.05 |
| Cl- (Repeatability) | Level 2: 1.5% CV | Level 2: CV ~0.0% | |
| Cl- (Repeatability) | Level 3: 1.7% CV | Level 3: CV ~0.1% | |
| Cl- (Within-Device Total) | Level 1: SD 2.5 | Level 1: SD ~0.13-0.24 | |
| Cl- (Within-Device Total) | Level 2: 1.8% CV | Level 2: CV ~0.1% | |
| Cl- (Within-Device Total) | Level 3: 2.0% CV | Level 3: CV ~0.1% | |
| Ca++ (Repeatability) | Level 1: 2.0% CV | Level 1: CV ~0.1-0.2% | |
| Ca++ (Repeatability) | Level 2: 2.0% CV | Level 2: CV ~0.0-0.4% | |
| Ca++ (Repeatability) | Level 3: SD 0.02 | Level 3: SD ~0.00 | |
| Ca++ (Within-Device Total) | Level 1: 2.5% CV | Level 1: CV ~0.1-0.3% | |
| Ca++ (Within-Device Total) | Level 2: 2.5% CV | Level 2: CV ~0.0-0.5% | |
| Ca++ (Within-Device Total) | Level 3: SD 0.03 | Level 3: SD ~0.00 | |
| K+ (Repeatability) | Level 1: SD 0.07 | Level 1: SD ~0.00 | |
| K+ (Repeatability) | Level 2: 1.5% CV | Level 2: CV ~0.1-0.2% | |
| K+ (Repeatability) | Level 3: 2.0% CV | Level 3: CV ~0.1-0.3% | |
| K+ (Within-Device Total) | Level 1: SD 0.10 | Level 1: SD ~0.00-0.01 | |
| K+ (Within-Device Total) | Level 2: 2.0% CV | Level 2: CV ~0.1-0.3% | |
| K+ (Within-Device Total) | Level 3: 2.5% CV | Level 3: CV ~0.1-0.4% | |
| 5-Day Repeatability (Whole Blood) | Cl- | All results within specification (implied from 20-day aqueous specs, though not explicitly restated for whole blood) | CVs generally 0.1-0.5% |
| Ca++ | All results within specification | CVs generally 0.2-1.0% (SDs 0.000-0.024) | |
| K+ | All results within specification | CVs generally 0.3-1.2% (SDs 0.006-0.093) | |
| Linearity Study | Cl-, Ca++, K+ | All analytes linear within the advertised reportable range (PASS in table) | All analytes demonstrated linearity with R2 values close to 1.000 (e.g., K+ 0.999-1.000, Ca++ 0.999-1.000, Cl- 0.999-1.000) |
| Method Comparison Study | K+ (e.g. at 3.00 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias 0.016 (CI 3.01-3.02), Total Allowable Error 2.50-3.50. Status: PASS |
| Cl- (e.g. at 90.0 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias 0.25 (CI 90.1-90.4), Total Allowable Error 85.5-94.5. Status: PASS | |
| Ca++ (e.g. at 0.37 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias -0.022 (CI 0.34-0.35), Total Allowable Error 0.27-0.47. Status: PASS | |
| Sensitivity Study | K+ | LoQ |
§ 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.