(190 days)
The LIAISON® XL 1,25 Dihydroxyvitamin D is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 1,25 dihydroxyvitamin (1,25(OH)2D) in serum, EDTA and Lithium Heparin plasma. Results of the 1,25 Dihydroxyvitamin D are used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in adult populations. The test is to be performed on the LIAISON® XL Analyzer.
The LIAISON® XL 1,25 Dihydroxyviamin D Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL 1,25 Dihydroxyvitamin D assay.
The LIAISON® XL 1.25 Dihydroxyvitamin D Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® XL1,25 Dihydroxyvitamin D assay.
The LIAISON® XL 1,25 Dihydroxyvitamin D assay is a modified three-step sandwich assay that uses a recombinant fusion protein for capture of the 1,25 (OH)> D molecule and a murine monoclonal antibody which specifically recognizes the complex formed by the recombinant fusion protein with the 1,25(OH)2 D molecule. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of 1,25(OH)> D present in the calibrators, controls or patient samples.
LIAISON® XL 1,25 Dihydroxyvitamin D Control set contains;
- 2 levels controls containing human serum spiked with 1,25 (OH)2 D, and . preservatives; 2 vials each level; lyophilized
The target concentration for control level 1 is 35 pg/mL. The target concentration for control Level 2 is 120 pg/mL.
The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® XL 1.25 Dihydroxyvitamin D Control set.
LIAISON® XL 1,25 Dihydroxyvitamin D Calibration Verifier set contains:
- 4 levels containing human serum spiked with 1,25 (OH), D, and preservatives, . 1 vial each level, lyophilized
The target concentration for cal verifier A is 15 pg/mL. The target concentration for cal verifier B is 40 pg/mL. The target concentration for cal verifier C is 80 pg/mL. The target concentration for cal verifier D is 150 pg/mL.
The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® XL 1,25 Dihydroxyvitamin D Calibration Verifier set.
The provided document is a 510(k) Summary for the LIAISON® XL 1,25 Dihydroxyvitamin D assay and its associated control and calibration verifier sets. This summary describes the device's intended use and provides performance characteristics to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each performance characteristic. Instead, it presents study results and implies that meeting these results demonstrates substantial equivalence. For instance, in the method comparison, a Deming Regression with a slope close to 1 and an intercept close to 0, and a high correlation coefficient (R) suggests good agreement. Similarly, for other studies like precision, linearity, and interference, the reported results are expected to fall within acceptable ranges for diagnostic assays, which are generally implied by the use of CLSI guidelines.
Therefore, the table below will summarize the reported performance as presented in the document, rather than explicit pre-defined acceptance criteria.
| Performance Characteristic | Reported Device Performance (LIAISON® XL 1,25 Dihydroxyvitamin D) | Predicate Device Performance (where applicable) |
|---|---|---|
| Method Comparison (vs. DiaSorin 1,25 Dihydroxyvitamin D 125I RIA) | Deming Regression: N=141, Slope = 0.973 (95% CI: 0.855 to 1.092), Intercept = -1.614 (95% CI: -7.475 to 4.248), R = 0.918 | - |
| Sample Matrix Comparison (vs. Serum) | SST Serum: Slope = 1.011 (0.99 to 1.03), Intercept = -0.285 (-1.08 to 0.83), R² = 0.9908 | |
| EDTA Plasma: Slope = 1.010 (0.98 to 1.04), Intercept = 0.321 (-1.15 to 1.64), R² = 0.9975 | ||
| Lithium Heparin: Slope = 1.0000 (0.97 to 1.04), Intercept = 0.1000 (-1.24 to 1.31), R² = 0.9957 | - | |
| Reference Range (U.S. Subjects, N=123) | Median = 47.8 pg/mL, Observed Range (2.5th to 97.5th Percentile) = 19.9 - 79.3 pg/mL | 25.1 - 66.1 pg/mL (for predicate) |
| Precision (Total %CV across lots) | Kit Control 1: 3.8% | |
| Kit Control 2: 3.6% | ||
| Prec Serum 1: 6.6% | ||
| Prec Serum 2: 5.7% | ||
| Prec Serum 3: 5.0% | ||
| Prec Serum 4: 4.1% | ||
| Prec Serum 5: 4.8% | ||
| Prec Serum 6: 5.9% | ||
| Cal Ver A: 5.7% | ||
| Cal Ver B: 3.5% | ||
| Cal Ver C: 3.6% | ||
| Cal Ver D: 3.7% | - | |
| Linearity (Dilution Linearity) | Observed 1,25 (OH)2 D = 0.981(Expected) + 0.005; R = 0.9994 | - |
| High Dose Hook Effect | No hook effect observed up to 5000 pg/mL of 1,25 (OH)2 D | - |
| Recovery Study (Mean Recovery) | 94% | - |
| Analytical Specificity (Cross-Reactivity) | 1,25 (OH)2 D3: 103.4% | |
| 1,25 (OH)2 D2: 104.8% | ||
| Zemplar: 113% | ||
| 25(OH)D3: |
§ 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.