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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.

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The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.

Blood gases (p02, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acidbase disturbances.

The EasyStat 300 is a system for use by health care professionals to rapidly analyze whole blood samples. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2, which is also use a calibrant for the Oxygen sensor. 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 EasyStat 300 uses 175μL of whole blood in the "Syringe" mode and 100μL of whole blood in the "Capillary" mode to analyze patient samples. The EasyStat 300 reports results for blood Gases (PCO2, PO2), and pH. 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. The EasyStat 300 is a microprocessor-controlled device with a touch sensitive screen that guides the operator through the different menu options and proper operation. It also incorporates a thermal printer to record all reported results and patient information as described in the Operator's Manual. The device software has incorporated routines to assist the end-user with maintenance, cleaning, and troubleshooting activities also outlined in the manual. The incorporated USB port may be used to download data and also to update the software version based on detailed instructions by Medica Corporation. The blood gas and pH sensors require calibration and cleaning after a predefined number of samples are analyzed as described in the Operator's Manual. The pH and PCO2 sensors are based on potentiometric sensor design, generating a small voltage that is dependent on the concentrations of these analytes in the patient sample. The PO2 sensor is based on amperometric sensor design that generates a small current that is dependent on the concentration of oxygen in the patient sample. Medica's EasyQC materials are specifically formulated for the EasyStat 300. The EasyStat 300 may be equipped with a Medica provided barcode scanner via a USB port to automatically enter patient sample and EasyQC material info. To maintain the performance of the analyzer Medica provides a cleaning solution and a troubleshooting kit.

Here's a breakdown of the acceptance criteria and the study that proves the EasyStat 300 device meets these criteria, based on the provided FDA 510(k) summary.

Key Findings from the Document:

• Device: EasyStat 300 Blood Gas Analyzer
• Purpose: Measures pO2, pCO2, and pH in whole blood.
• Comparison: Substantially equivalent to its predicate device, the EasyStat Blood Gas Analyzer (K021515).
• Studies Conducted: Precision (Repeatability, Reproducibility), Linearity, Method Comparison, Sensitivity, and Selectivity (Interference).
• Ground Truth for Analytical Studies: Primarily based on pre-assayed whole blood samples, aqueous QC materials, and tonometered whole blood, with comparisons against results from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table labeled "Acceptance Criteria," but rather presents "Performance Specs" within the precision studies and "Status" (PASS) for linearity and method comparison, indicating adherence to pre-defined criteria. The interference study uses a "Conclusion" column based on a predefined percentage change. Based on the data provided, the acceptance criteria are inferred from the "Performance Specs" headers and the overall "PASS" status for each test.

• System 1 PO2 Level 1: 1.39 SD (vs 2.5 SD)
• System 1 PCO2 Level 1: 0.9 CV (vs 5.0% CV)
• System 1 pH Level 1: 0.002 SD (vs 0.020 SD)

Aqueous Controls (Capillary Mode): All results "within specification." Examples:

• Unit 1 PO2 Level 1: 2.70 SD (vs 3 SD)
• Unit 1 PCO2 Level 1: 1.5 CV (vs 5.0% CV)
• Unit 1 pH Level 1: 0.004 SD (vs 0.020 SD) |
  | Reproducibility | pO2: Level 1: 2.5mmHg; Level 2: 2.5mmHg; Level 3: 3.0% CV | 5-day w. Blood Study (Syringe Mode): All results "within specification." Examples:
• PO2 Level 1: 0.6 SD (vs 2.5mmHg)
• PCO2 Level 1: 0.5 SD (vs 2.0% CV, implied from table structure)
• pH Level 1: 0.007 SD (vs 0.015 units)

5-day w. Blood Study (Capillary Mode): All results "within specification." Examples:

• PO2 Level 1: 0.9 SD (vs 2.4mmHg)
• PCO2 Level 1: 2.5 CV (vs 4.0% CV)
• pH Level 1: 0.008 SD (vs 0.015 units) |
  | Linearity | "met all device specifications" (implied criteria typically high R^2 values, slope ~1) | Data shown (e.g., for ES300-P7):
• PO2 (Syringe): R² 0.999, Slope 1.016 (PASS)
• PCO2 (Syringe): R² 0.999, Slope 1.066 (PASS)
• pH (Syringe): R² 0.996, Slope 1.008 (PASS)
  Conclusion: "all analytes... are linear within the advertised reportable range." |
  | Method Comparison | "linear regression slope, the coefficient of variation, and the calculated predicted bias at the decision levels for each analyte were within specifications." (implied) | Exemplified by PO2 Syringe Mode:
• n=272, Slope=1.001, R²=0.999
• Predicted Bias for PO2 (30.0, 45.0, 60.0): All PASS ("within specifications," typically close to 0 bias and CI within allowable error).
  Conclusion: "all analytes... are favorably correlated to the predicate/reference device... within specifications." |
  | Sensitivity | LoQ

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