(308 days)
This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.
The Prestige 24i with Ion Selective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Prestige 24i (and equivalent models) details performance characteristics. The acceptance criteria themselves are not explicitly stated as pass/fail thresholds in the document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Roche Cobas Mira Plus) through correlation, linearity, and precision. The reported performance is presented to support this claim of equivalence.
Given this, the table below presents the reported performance values. The implied acceptance criteria are that these values should be comparable to or within acceptable ranges for similar clinical chemistry analyzers for the measurement of sodium, potassium, and chloride, especially when compared to the predicate device.
| Performance Characteristic | Analyte | Reported Device Performance (Prestige 24i) | Implied Acceptance Criteria (Based on Substantial Equivalence) |
|---|---|---|---|
| Correlation Analysis | Correlation Coefficient (r): High (e.g., typically >0.95 for good agreement, though specific threshold not stated). | ||
| Slope (Least-Squares): Close to 1.0 (indicating proportional agreement). | |||
| Y-axis intercept: Close to 0 (indicating minimal constant bias). Values presented are considered acceptable for substantial equivalence. | |||
| Sodium | r = 0.97, Slope = 0.95, Intercept = +6.8625 mmol/L | ||
| Potassium | r = 0.99, Slope = 0.98, Intercept = -0.0135 mmol/L | ||
| Chloride | r = 0.98, Slope = 0.97, Intercept = +3.2579 mmol/L | ||
| Linearity | The device should be linear over the clinically relevant range for each analyte; the reported ranges are considered acceptable. | ||
| Sodium | 70 - 200 mmol/L (Serum) | ||
| Potassium | 1 - 50 mmol/L (Serum) | ||
| Chloride | 70 - 200 mmol/L (Serum) | ||
| Precision (Within Run) | Coefficient of Variation (%CV): Low (typically |
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.