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510(k) Data Aggregation
(368 days)
25-Hydroxy Vitamin Ds EIA
The 25-Hydroxy Vitamin DS EIA assay is intended for the quantitative determination of 25-hydroxyvitamin D [25(OH)D] and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.
The 25-Hydroxy Vitamin De EIA is a manual assay test and does not require the use of an automated system. The whole assay is performed in a microtitre plate and requires a user to perform each step. The 25-Hydroxy Vitamin De assay is an enzymeimmunoassay for the quantitation of 25(OH)D and other hydroxylated metabolites in serum or plasma. 25uL of each calibrators, controls and samples are diluted with biotin labelled 25(OH)D. The diluted samples are incubated in microtitre wells which are coated with a highly specific sheep 25(OH)D at room temperature before aspiration and washing. Enzyme (horseradish peroxidase) labelled avidin, is added and binds selectively to complexed biotin and, following a further wash step, colour is developed using a chromogenic substrate (TMB). The absorbance of the stopped reaction mixtures are read in a microtitre plate reader, colour intensity developed being inversely proportional to the concentration of 25(OH)D.
The provided document describes the performance characteristics of the 25-Hydroxy Vitamin D EIA assay, but it focuses on analytical and comparative performance rather than a study proving the device meets general acceptance criteria in a clinical setting with human readers. The document is for an in-vitro diagnostic (IVD) device, so the criteria and studies described are relevant to laboratory performance.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text, adapted for an IVD context where appropriate:
1. A table of acceptance criteria and the reported device performance
For IVD devices, "acceptance criteria" are usually internal performance goals set by the manufacturer to demonstrate analytical and clinical performance required for regulatory clearance. The document lists several performance characteristics and provides the corresponding measurements for the candidate device and, in some cases, the predicate device.
| Performance Characteristic | Acceptance Criteria (from text or implied) | Reported Device Performance (Candidate Device) |
|---|---|---|
| Traceability | Traceable to ID-LCMS/MS 25(OH) Vitamin D RMP (VDSP standard) | Traceable to ID-LCMS/MS RMP (VDSP human serum panel) and certified by CDC VDSP |
| Stability (Kit) | 8 months when stored at 2-8°C | 8 months when stored at 2-8°C |
| Stability (Open Vial) | (Implied: adequate for practical use) | Reconstituted Biotin 25(OH)D Solution: 8 weeks (2-8°C, dark) |
| Unused Ab. coated plate strip: 8 weeks (2-8°C, foil pouch) | ||
| Calibrators, Controls: 8 weeks (2-8°C) | ||
| Wash Solution: 8 weeks (room temp, after prep) | ||
| Limit of Blank (LoB) | (Implied: sufficiently low) | 1.3 ng/mL (4.5 nmol/L) |
| Limit of Detection (LoD) | (Implied: sufficiently low) | 2.7 ng/mL (6.9 nmol/L) |
| Limit of Quantitation (LoQ) | (Implied: sufficiently low) | 4.8 ng/mL (12.0 nmol/L) |
| Cross-Reactivity (25(OH)D3) | (Implied: high expected, near 100%) | 95% |
| Cross-Reactivity (25(OH)D2) | (Implied: high expected, near 100%) | 109% |
| Interference (Triglycerides) | No interference up to 475 mg/dL | No interference up to 475 mg/dL |
| Interference (Bilirubin conjugated) | No interference up to 20 mg/dL | No interference up to 20 mg/dL |
| Interference (Haemoglobin) | No interference up to 400 mg/dL | No interference up to 400 mg/dL |
| Interference (HAMA) | No interference up to 1000 ng/mL | No interference up to 1000 ng/mL |
| Interference (Rheumatoid Factor) | No interference up to 800 IU/mL | No interference up to 800 IU/mL |
| Interference (Red Blood Cells) | No interference up to 0.4% | No interference up to 0.4% |
| Interference (Vitamin D Binding Proteins) | No interference up to 2000 ng/dL | No interference up to 2000 ng/dL |
| Interference (Total Protein) | No interference up to 9.2 g/dL | No interference up to 9.2 g/dL |
| Interference (Cholesterol, Total) | No interference up to 500 mg/dL | No interference up to 500 mg/dL |
| Interference (Biotin) | No interference up to 200 nmol/L | No interference up to 200 nmol/L |
| Method Comparison (vs. Predicate) Slope | 0.85 to 1.15 | 0.88 (Passing Bablok), 0.82 (Linear Reg) |
| Method Comparison (vs. Predicate) Intercept | +/- 7 ng/mL | 3.23 ng/mL (Passing Bablok), 4.86 ng/mL (Linear Reg) |
| Method Comparison (vs. Predicate) Correlation (r) | ≥ 0.90 | 0.97 |
| Method Comparison (vs. Reference) Slope | 0.88 to 1.02 (95% CI from study) | 0.96 (Passing Bablok), 0.97 (Deming Reg) |
| Method Comparison (vs. Reference) Intercept | -1.62 to 1.88 ng/mL (95% CI from study) | -0.11 ng/mL (Passing Bablok), -0.84 ng/mL (Deming Reg) |
| Method Comparison (vs. Reference) Correlation (r) | 0.947 (from study) | 0.947 |
| Precision (Total %CV) | (Implied: acceptable for diagnostic assay) | 3.7% to 11.5% across 11.7 to 65.1 ng/mL |
| Linearity (Regression Coefficient R²) | (Implied: close to 1.00) | 1.00 |
| Linearity (Max Deviation) | (Implied: acceptable limits) | -8.8% (>20ng/mL), 2.37 ng/ml ( |
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