(26 days)
used to measure creatinines concentrations in serum, plasma, or urine on the SYNCHRON CX 3 System
Creatinine Reagent Set, Procedure Number C7058, is formulated based on a modification of the Jaffe reagents described by Heinegard and Tiderstrom.
This document describes a diagnostic reagent set, not a device that involves artificial intelligence, image analysis, or complex algorithms that would require the specified criteria like expert ground truth, MRMC studies, or multi-reader scenarios. The "device" in this context is primarily a chemical reagent.
Therefore, many of the requested categories are not applicable to the information provided. However, I can extract the relevant performance data and address the applicable points.
Here's the information based on the provided text for the Sigma Diagnostics CX®3 Creatinine Reagent Set:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Correlation with Predicate Device (Serum) | High correlation (implied: close to 1) | 0.999 |
| Regression (Serum) | Regression equation close to y=x (implied: slope near 1, intercept near 0) | y = 1.03x - 0.01 |
| Correlation with Predicate Device (Urine) | High correlation (implied: close to 1) | 0.998 |
| Regression (Urine) | Regression equation close to y=x (implied: slope near 1, intercept near 0) | y = 0.99x + 0.21 |
| Within-run Precision (%CV) - Serum | %CV |
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.