(364 days)
The i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge) is a portable, automated system that measures pH and blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-) and hematocrit in arterial and venous whole blood samples with lithium heparin or calcium balanced heparin. The system is intended for in-vitro diagnostic use only by trained health care professionals in a laboratory environment, near patient or point-of-care settings.
pH, pCO2, pO2: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base and/or oxygenation disturbances.
Hct: Whole blood measurements of the packed cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red blood cells)
Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
K+: Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ca++: Calcium 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).
The EDAN i15 Calibrant Fluid Pack is intended for the calibration of pH, pO2, pCO2, Na+, K+ Ca++, Cl-, and Hct as part of the EDAN i15 Blood Gas and Chemistry Analysis System.
The EDAN i15 Blood Gas and Electrolyte Controls are external multi-analyte quality control material intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Electrolyte Analyze, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of pH, blood gases (pCO2 pO2), and electrolytes (Na+, K+, Ca++, and Cl').
The EDAN i15 Hematocrit Controls are intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Chemistry Analysis System, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of hematocrit.
The EDAN i15 Blood Gas and Chemistry Analysis System, including the Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge, and Quality Controls) is a system for in-vitro analysis of whole blood, delivering quantitative results for panels of tests determined by the Test Cartridge type used in the measurement. The Analyzer incorporates a large graphical user interface with a large color touch screen interfacing the analyzer electronic, Test Cartridge (containing the sensors) and Calibrant Fluid Pack. The sensors, flow path and waste are integrated into a single-use Test Cartridge. The calibration solution is contained in the Calibrant Fluid Pack which is available in versions for 50 or 100 tests. The product, consumables, installation instructions and packaging are designed for easy customer installation and operation.
The EDAN i15 Analyzer accepts lithium- or calcium-balanced heparinized whole blood samples from syringes and capillary tube. The minimum volume for samples from both syringe and capillary tube is 140 µL.
As with the predicate device, the EDAN i15 Blood Gas and Chemistry Analysis System is microprocessor-based and incorporates traditional sensor technology for measurement.
- pH, pCO2, Na*, K*, Cl , and Ca** (potentiometric measurement) .
- pO2 (amperometric measurement)
- Hct (conductivity measurement) ●
The Test Cartridge is available in three (3) versions, with different test panels, but with identical sample paths and calibration fluid:
BG8: pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct
BG3: pH, pCO2, pO2
BC4: Na+, K+, Cl-, Ca++, Hct
The Test Cartridge aspirates the sample directly from a syringe, or capillary fitted with an adaptor, and requires a minimum sample volume of 140 µL.
The provided text describes the performance testing and acceptance criteria for the EDAN i15 Blood Gas and Chemistry Analysis System.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Measurand | Acceptance Criteria for Linearity (Slope, Intercept, r-value) | Reported Linearity Performance (Syringe) (Slope, Intercept, r-value) | Reported Linearity Performance (Capillary) (Slope, Intercept, r-value) | Acceptance Criteria for Interferents | Reported Interferent Performance (Examples of significant interference listed below) |
|---|---|---|---|---|---|---|
| Linearity | Na+ | Slope [0.95, 1.05], r-value ≥ 0.975 | 0.9923, -1.38, 0.9983 | 1.0059, -3.06, 0.9986 | - | - |
| K+ | Slope [0.95, 1.05], r-value ≥ 0.975 | 0.9886, 0.08, 0.9997 | 1.0013, -0.01, 0.9998 | - | - | |
| Cl- | Slope [0.95, 1.05], r-value ≥ 0.975 | 1.0028, -1.59, 0.9993 | 0.9965, -1.59, 0.9992 | - | - | |
| Ca++ | Slope [0.95, 1.05], r-value ≥ 0.975 | 0.9848, -0.05, 0.9981 | 0.9771, -0.06, 0.9968 | - | - | |
| pH | Slope [0.95, 1.05], r-value ≥ 0.975 | 0.9842, 0.11, 0.9996 | 1.0039, -0.03, 0.9995 | - | - | |
| pCO2 | Slope [0.95, 1.05], r-value ≥ 0.975 | 0.9533, 0.62, 0.9969 | 0.9999, -0.06, 0.9992 | - | - | |
| pO2 | Slope [0.95, 1.05], r-value ≥ 0.975 | 0.9969, -6.16, 0.9993 | 1.0174, -5.40, 0.9997 | - | - | |
| Hct | Slope [0.95, 1.05], r-value ≥ 0.975 | 0.9687, 1.54, 0.9981 | 0.9623, 1.51, 0.9984 | - | - | |
| Specificity/Interference | pH | Absolute difference |
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.