(37 days)
The Cyclosporine CSAE Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) in human whole blood for the Dimension® clinical chemistry system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
The Dimension® CSAE Cyclosporine Flex® reagent cartridge (DF108) is an in vitro rine Differences that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension® clinical chemistry system for the quantitative determination cyclosporine A (CSA) in human whole blood.
Here's an analysis of the provided text regarding the Dimension® Cyclosporine CSAE Flex® reagent cartridge, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for most performance characteristics. Instead, it reports the performance values observed during the studies. For linearity and functional sensitivity, implicit criteria can be inferred.
| Performance Characteristic | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance |
|---|---|---|
| Reproducibility | Not explicitly stated | Whole Blood Pool 1: |
| Repeatability SD: 12.21 (3.32%CV) | ||
| Within-lab SD: 19.00 (5.16%CV) | ||
| Whole Blood Pool 2: | ||
| Repeatability SD: 30.65 (2.73%CV) | ||
| Within-lab SD: 57.24 (5.10%CV) | ||
| Whole Blood Pool 3: | ||
| Repeatability SD: 46.72 (2.64%CV) | ||
| Within-lab SD: 104.07 (5.29%CV) | ||
| More Control 1: | ||
| Repeatability SD: 13.99 (2.86%CV) | ||
| Within-lab SD: 28.77 (5.89%CV) | ||
| More Control 2: | ||
| Repeatability SD: 18.61 (2.15%CV) | ||
| Within-lab SD: 47.71 (5.51%CV) | ||
| More Control 3: | ||
| Repeatability SD: 34.41 (2.64%CV) | ||
| Within-lab SD: 68.89 (5.29%CV) | ||
| Method Comparison | Not explicitly stated (Implicit: good correlation with predicate and LC/MS) | vs. Abbott TDx® (All): |
| Slope: 1.13 | ||
| Intercept: -67.2 | ||
| Correlation Coefficient: 0.980 | ||
| vs. LCMS (All): | ||
| Slope: 1.09 | ||
| Intercept: 17.1 | ||
| Correlation Coefficient: 0.986 | ||
| Linearity | Deviation from estimated line |
§ 862.1235 Cyclosporine test system.
(a)
Identification. A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.