(27 days)
The LIAISON® 25 TOTAL-D assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA and Lithium heparin plasma. The LIAISON® 25 TOTAL-D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The DiaSorin LIAISON® 25 TOTAL-D is intended to be used on the LIAISON® XL Analyzer.
The DiaSorin LIAISON® 25 TOTAL-D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 TOTAL-D assay.
The DiaSorin LIAISON® 25 TOTAL-D Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® 25 TOTAL-D assay when performed on the LIAISON® XL Analyzer.
The LIAISON® 25 TOTAL-D consists of one Reagent Intergral with calibrators, which consists of: Magnetic Particles (2.4 mL) coated with goat antibody against 25 OH Vitamin D, protein, phosphate buffer,
The DiaSorin LIAISON® 25 TOTAL-D assay is a chemiluminescent immunoassay (CLIA) for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA, and Lithium heparin plasma. It is intended to be an aid in the assessment of vitamin D sufficiency in adults.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as pass/fail thresholds for each metric in the provided text. However, the study results are presented with implied acceptance based on the comparison to the predicate device and established clinical laboratory guidelines (e.g., CLSI documents).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Slope between 0.90-1.10 and high correlation to predicate. | N=391 |
| Slope: 0.99 (95% CI: 0.97-1.01) | ||
| Intercept: -0.22 (95% CI: -0.51-0.08) | ||
| Correlation Coefficient: 0.990 | ||
| Matrix Comparison (SST Serum vs. Serum) | Slope between 0.90-1.10 compared to serum. | Slope: 0.9942 (95% CI: 0.9785 to 1.0113) |
| Y-intercept: 0.4098 (95% CI: -0.1694 to 1.1652) | ||
| Matrix Comparison (EDTA Plasma vs. Serum) | Slope between 0.90-1.10 compared to serum. | Slope: 1.0092 (95% CI: 0.9916 to 1.0253) |
| Y-intercept: -0.5785 (95% CI: -1.1028 to -0.0976) | ||
| Matrix Comparison (Lithium Heparin Plasma vs. Serum) | Slope between 0.90-1.10 compared to serum. | Slope: 1.0007 (95% CI: 0.9869 to 1.0180) |
| Y-intercept: -0.0211 (95% CI: -0.5554 to 0.4683) | ||
| Linearity/Measuring Range | Linear regression fit with statistically insignificant second and third order terms in serum, and a measuring range of 4-150 ng/mL. | Serum: y = 1.025x - 0.6094 |
| SST: y = 1.0064x - 0.3887 | ||
| EDTA: y = 1.0092x - 0.4958 | ||
| Li-Heparin: y = 1.0421x - 0.8295. Polynomial regression for serum showed statistically insignificant higher-order terms. Supports 4-150 ng/mL range. | ||
| LoB (Limit of Blank) | Not explicitly stated, but within expected assay limits. |
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.