(35 days)
The AVL 9181 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 9181 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. The AVL 9181 is an improved design of our existing 9180 Electrolyte Analyzer [K961458] with the addition of an Autosampler to allow automatic sampling of up to 18 sample cups. The 9181 is exactly equivalent to the AVL 9180 with the exception of this single, additional feature. The manual needle mechanism of the 9180 was replaced with the automated needle mechanism from the AVL 988-4. The electronic circuitry to control the needle mechanism are incorporated into the 9180 display board. The sampler is taken from the 988-4 without modification except that the connector is changed to a smaller type. The 9180 main board already incorporated the controller for the sampler. The 9180 software was modified to add the automatic sampling feature. Calibration and measurement sequences are taken without alteration from the 9180 (sample volume, timing and algorithms). Once the sample probe is positioned in the sample cup, aspiration, measurement, wash and recalibration sequences are identical to the 9180.
Here's a breakdown of the acceptance criteria and study information for the AVL 9181 Electrolyte Analyzer, based on the provided text:
AVL 9181 Electrolyte Analyzer: Acceptance Criteria and Study Details
The provided document describes the AVL 9181 Electrolyte Analyzer as an improved design of the existing AVL 9180 Electrolyte Analyzer [K961458], with the primary addition of an Autosampler. The studies presented focus on demonstrating that this new feature, and the overall device, performs equivalently to the predicate devices and existing manual methods.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined "acceptance criteria" in the format of specific thresholds for accuracy, precision, etc. Instead, it describes performance characteristics that were evaluated and concluded to be comparable to predicate devices and manual methods. The general acceptance criterion appears to be "no significant difference" (p wr), Between-Day (Sdd), and Total (ST) Precision determined. Tests performed in manual and automated modes. Conclusion: "no significant difference in performance exists between the 9181 in automated and manual measurement modes; and between the 9181 and its predecessor, the AVL 9180." |
| Linearity (N.I.S.T. SRM 956a) | Strong correlation (R-value close to 1) and low Syx. | Sodium: Slope 1.0134, Intercept -2.5307, Correlation Coefficient 0.99988, Syx 0.2709
Potassium: Slope 1.0133, Intercept -0.0230, Correlation Coefficient 0.99996, Syx 0.0166
Lithium: Slope 0.9717, Intercept 0.0482, Correlation Coefficient 0.99998, Syx 0.0067
(Note: This demonstrates linearity, but a direct comparison to an acceptance threshold isn't stated.) |
| Linearity (Serum) | Equivalent linearity to predicate methods; no significant difference (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.