(58 days)
The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.
The AVL 9180 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results.
In the blood, serum and QC measuring modes, the results for sodium and potassium are reported by default as flame photometry equivalent; chloride, ionized calcium and lithium are reported as ISE direct potentiometric values. The urine mode allows for the measurement of prediluted urine samples for sodium, potassium and chloride. The acetate, bicarbonate and standard modes allow for the measurement of aqueous standards and dialysate solutions and reports as ISE direct potentiometric values.
The provided text describes the AVL 9180 Electrolyte Analyzer, an ion-specific electrolyte analyzer for measuring sodium, potassium, chloride, ionized calcium, and lithium. The submission focuses on demonstrating the substantial equivalence and performance of the new device compared to existing predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text (e.g., "correlation coefficient > 0.95"). Instead, the document implies that the device meets acceptance criteria if its performance is comparable to predicate devices and falls within "manufacturers claims and expectations." The core of the performance evaluation relies on correlation coefficients, slopes, and intercepts from comparative studies, demonstrating the agreement between the AVL 9180 and established methods.
The tables presented in the document are the reported device performance. I will present a summary table outlining the key performance metrics from the various comparative studies, grouped by parameter and comparator.
| Parameter | Performance Metric (Type of Study) | Reported Value / Range | Indication of Acceptance |
|---|---|---|---|
| Sodium (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99995 | Excellent linearity |
| Slope (Linearity) | 0.99993 | Close to ideal slope of 1 | |
| Intercept (Linearity) | 0.0128 | Close to ideal intercept of 0 | |
| Potassium (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99919 | Excellent linearity |
| Slope (Linearity) | 0.99838 | Close to ideal slope of 1 | |
| Intercept (Linearity) | 0.0119 | Close to ideal intercept of 0 | |
| Chloride (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99994 | Excellent linearity |
| Slope (Linearity) | 0.97556 | Close to ideal slope of 1 | |
| Intercept (Linearity) | -0.1775 | Close to ideal intercept of 0 | |
| Ionized Calcium (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99980 | Excellent linearity |
| Slope (Linearity) | 1.01552 | Close to ideal slope of 1 | |
| Intercept (Linearity) | -0.0078 | Close to ideal intercept of 0 | |
| Lithium (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99985 | Excellent linearity |
| Slope (Linearity) | 0.99850 | Close to ideal slope of 1 | |
| Intercept (Linearity) | 0.0087 | Close to ideal intercept of 0 | |
| Sodium (Serum vs. Flame Absorbance) | Correlation Coefficient | 0.9908 | Very good correlation |
| Slope | 0.9617 | Close to ideal slope of 1 | |
| Potassium (Serum vs. Flame Absorbance) | Correlation Coefficient | 0.9991 | Excellent correlation |
| Slope | 1.0249 | Close to ideal slope of 1 | |
| Lithium (Serum vs. Flame Absorbance) | Correlation Coefficient | 0.9822 | Very good correlation |
| Slope | 0.9803 | Close to ideal slope of 1 | |
| Sodium (Serum vs. ISE Direct Potentiometry - AVL 983) | Correlation Coefficient | 0.9992 | Excellent correlation |
| Slope | 0.9895 | Close to ideal slope of 1 | |
| Potassium (Serum vs. ISE Direct Potentiometry - AVL 983) | Correlation Coefficient | 0.9996 | Excellent correlation |
| Slope | 1.0223 | Close to ideal slope of 1 | |
| Chloride (Serum vs. ISE Direct Potentiometry - AVL 983) | Correlation Coefficient | 0.9995 | Excellent correlation |
| Slope | 0.9631 | Close to ideal slope of 1 | |
| Ionized Calcium (Serum vs. ISE Direct Potentiometry - AVL 984) | Correlation Coefficient | 0.9960 | Excellent correlation |
| Slope | 0.8898 | Good correlation, slightly lower slope | |
| Lithium (Serum vs. ISE Direct Potentiometry - AVL 985) | Correlation Coefficient | 0.9985 | Excellent correlation |
| Slope | 0.9923 | Close to ideal slope of 1 | |
| Sodium (Serum vs. Flame Correlation - AVL 9130, 9140) | Correlation Coefficient | 0.9856 | Very good correlation |
| Potassium (Serum vs. Flame Correlation - AVL 9130, 9140) | Correlation Coefficient | 0.9994 | Excellent correlation |
| Chloride (Serum vs. Flame Correlation - AVL 9130, 9140) | Correlation Coefficient | 0.9989 | Excellent correlation |
| Ionized Calcium (Serum vs. Flame Correlation - AVL 9130, 9140) | Correlation Coefficient | 0.9954 | Excellent correlation |
| Sodium (Urine vs. direct ISE - AVL 983) | Correlation Coefficient | 0.9973 | Excellent correlation |
| Slope | 1.0173 | Close to ideal slope of 1 | |
| Potassium (Urine vs. direct ISE - AVL 983) | Correlation Coefficient | 0.9976 | Excellent correlation |
| Slope | 1.0312 | Close to ideal slope of 1 | |
| Chloride (Urine vs. direct ISE - AVL 983) | Correlation Coefficient | 0.9972 | Excellent correlation |
| Slope | 0.9817 | Close to ideal slope of 1 | |
| Sodium (Urine vs. Flame Absorbance - IL 943) | Correlation Coefficient | 0.9901 | Very good correlation |
| Slope | 0.9173 | Good correlation, slightly lower slope | |
| Potassium (Urine vs. Flame Absorbance - IL 943) | Correlation Coefficient | 0.9976 | Excellent correlation |
| Slope | 1.0312 | Close to ideal slope of 1 | |
| Chloride (Urine vs. Chloridometry - Labconco Digital) | Correlation Coefficient | 0.9972 | Excellent correlation |
| Slope | 0.9817 | Close to ideal slope of 1 | |
| Sodium (Clinical vs. KODAK Ektachem XR700) | Correlation Coefficient | 0.9495 | Good correlation |
| Potassium (Clinical vs. KODAK Ektachem XR700) | Correlation Coefficient | 0.9873 | Very good correlation |
| Chloride (Clinical vs. KODAK Ektachem XR700) | Correlation Coefficient | 0.9762 | Very good correlation |
| Clinical Field Tests (example data presented) | No difference in mean values | P |
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. 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).(b)
Classification. Class II.