(236 days)
• Elecsys Vitamin D Reagent:
The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults.
The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
• Elecsys Vitamin D CalSet: Elecsys Vitamin D CalSet is used for calibrating the quantitative Elecsys Vitamin D assay on the Elecsys and cobas e immunoassay analyzers.
• Elecsys PreciControl Varia 3: Elecsys PreciControl Varia 3 is used for quality control of the specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
• Elecsys Vitamin D CalCheck 5: The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Vitamin D Assay is a competitive protein binding assay which uses Vitamin D Binding Protein instead of monoclonal antibodies for detection of 25-Hydroxyvitamin D. The total duration of the assay is 27 minutes. The sample is treated with pretreatment reagent in the first incubation period. This releases any vitamin D from the endogenous vitamin D binding protein present in the patient's sample. In the next incubation, vitamin D binding protein labeled with ruthenium is added and a complex is formed between the vitamin D (25-OH) and the ruthenylated vitamin D binding protein. In the 30 and final incubation, streptavidin-coated microparticles are added along with vitamin D (25-OH) labeled with biotin. Any unbound ruthenium labeled vitamin D binding proteins become occupied with biotin-labeled vitamin D (25-OH). The complex consisting of the ruthenylated vitamin D binding protein and the biotinylated vitamin D (25-OH) becomes bound to the solid phase via interaction of the biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the electrochemiluminescence emission is detected. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration provided with the reagent bar code.
(2) The Elecsys Vitamin D CalSet is a lyophilized product based on human serum. It has been standardized against LC-MS/MS, which has in turn been standardized to the NIST standard. .
(3) The Elecsys PreciControl Varia 3 is a multi-composite lyophilized 3 level control set which has been previously cleared for 7 components . The Elecsys PreciControl Varia 3 has been cleared under K111506 for the following analytes: Vitamin B12, Ferritin, Folate III, betaCrossLaps/Serum (-CTx), Osteocalcin, Parathyroid Hormone, Parathyroid Hormone Short Turnaround Time (PTH-STAT).
(4) The Elecsys Vitamin D CalCheck 5 contains 5 lyophilized levels based on human serum.
The provided document describes the Elecsys Vitamin D Assay and its associated calibrators and controls. The acceptance criteria and the study that proves the device meets the acceptance criteria are mainly focused on the Elecsys Vitamin D Assay itself, with comparisons to a predicate device and LC-MS/MS.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with numerical targets. Instead, it presents "Labeled Performance Characteristics" which serve as the performance specifications the device aims to meet. The comparison to the predicate device and LC-MS/MS provides evidence of its performance.
| Performance Characteristic | Acceptance Criteria (Implied / Predicate) | Elecsys Vitamin D Assay Performance |
|---|---|---|
| Measuring Range | Predicate: 13-96 ng/mL | 5-60 ng/mL (This is a key difference, indicating a wider lower range for the Elecsys) |
| Precision (Within-run) | Predicate: 3.1% CV @ 23.0 ng/mL, 2.6% CV @ 42.5 ng/mL, 1.4% CV @ 75.4 ng/mL | Elecsys 2010/cobas e 411 (n=84, human sera): |
| 7.2% CV @ 6.2 ng/mL | ||
| 5.1% CV @ 11.2 ng/mL | ||
| 2.9% CV @ 23.2 ng/mL | ||
| 2.4% CV @ 45.3 ng/mL | ||
| 1.6% CV @ 52.6 ng/mL | ||
| Precision (Total) | Predicate: 4.0% CV @ 23.0 ng/mL, 3.2% CV @ 42.5 ng/mL, 2.7% CV @ 75.4 ng/mL | Elecsys 2010/cobas e 411: |
| 10.3% CV @ 6.2 ng/mL | ||
| 7.6% CV @ 11.2 ng/mL | ||
| 5.3% CV @ 23.2 ng/mL | ||
| 3.4% CV @ 45.3 ng/mL | ||
| 2.9% CV @ 52.6 ng/mL | ||
| Analytical Sensitivity | Predicate: Limit of Blank: 1.9 ng/mL, Limit of Detection: 3.1 ng/mL, Limit of Quantitation (LoQ): 8.0 ng/mL | Limit of Blank (LoB): 2.00 ng/mL |
| Limit of Detection (LoD): 3.00 ng/mL | ||
| Limit of Quantitation (LoQ): 5.00 ng/mL (Lower LoQ than predicate) | ||
| Analytical Specificity (Cross Reactivity) | Predicate cross-reactivity percentages for various Vitamin D metabolites (e.g., 25-hydroxyvitamin D3: 105%, 25-hydroxyvitamin D2: 82%, 24,25-hydroxyvitamin D3: 112%, 1,25-hydroxyvitamin D3: 12.6%) | Elecsys cross-reactivity percentages: |
| 25-hydroxyvitamin D3: 100% | ||
| 25-hydroxyvitamin D2: 92% | ||
| 24,25-hydroxyvitamin D3: 149% | ||
| 1,25-hydroxyvitamin D3: not detected | ||
| 1,25-hydroxyvitamin D2: not detected | ||
| Vitamin D3: not detected | ||
| Vitamin D2: not detected | ||
| C3-epimer of 25-hydroxyvitamin D3: 91% | ||
| Method Comparison (vs. LC-MS/MS) | N/A (Comparison with a Gold Standard for traceability) | Deming (n=290): Slope: 1.03, Intercept: -3.07, r: 0.85 |
| Method Comparison (vs. Predicate) | N/A (Comparison with the predicate device to demonstrate substantial equivalence) | Deming (n=165): Slope: 0.99, Intercept: 1.20, r: 0.91 |
| Hook Effect | Predicate: Unknown | There is no high-dose hook effect since the Elecsys Vitamin D assay is a competitive assay. |
| Interference | Predicate: Unaffected by Hemoglobin |
§ 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.