(35 days)
The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
The Dimension® IRON Flex® reagent cartridge (DF85) is an in vitro diagnostic device 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 of iron in serum and plasma.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Based on CLSI/NCCLS EP5-A2 guideline. Specific CV% targets are implied by showing results within acceptable clinical ranges. | Repeatability (%CV): |
| Plasma pool: 0.5% | ||
| Serum pool 1: 0.5% | ||
| Serum pool 2: 0.5% | ||
| Serum pool 3: 0.5% | ||
| BioRad Lyphochek® control Level 1: 0.5% | ||
| BioRad Lyphochek® control Level 2: 1.1% | ||
| BioRad Lyphochek® Anemia control Level 1: 1.3% | ||
| Reduced Sample Volume Serum pool 1: 0.6% | ||
| Reduced Sample Volume Serum pool 2: 0.5% | ||
| Reduced Sample Volume Serum pool 3: 0.5% | ||
| Reduced Sample Volume BioRad Lyphochek® Anemia control Level 1: 1.3% | ||
| Reduced Sample Volume BioRad Multiqual® control Level 3: 0.7% |
Within-lab Standard Deviation (%CV):
Plasma pool: 0.7%
Serum pool 1: 0.6%
Serum pool 2: 1.1%
Serum pool 3: 0.8%
BioRad Lyphochek® control Level 1: 0.7%
BioRad Lyphochek® control Level 2: 1.9%
BioRad Lyphochek® Anemia control Level 1: 1.9%
Reduced Sample Volume Serum pool 1: 0.9%
Reduced Sample Volume Serum pool 2: 1.1%
Reduced Sample Volume Serum pool 3: 0.8%
Reduced Sample Volume BioRad Lyphochek® Anemia control Level 1: 1.9%
Reduced Sample Volume BioRad Multiqual® control Level 3: 0.9% |
| Linearity/Assay Reportable Range | Correlation coefficient of 0.999, slope of 0.999, and intercept of 0.178. Assay range claim: 5.0 µg/dL to 1000 µg/dL. | Correlation Coefficient: 0.999
Slope: 0.999
Intercept: 0.178
Assay Range Claim: 5.0 µg/dL to 1000 µg/dL |
| Detection Limit (Analytical Sensitivity) | Ability to distinguish iron from zero. | Analytical Sensitivity: 5 µg/dL [0.9 µmol/L] |
| Analytical Specificity (Interference) | Systematic inaccuracies (bias) due to interfering substances
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(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 the limitations in § 862.9.