(120 days)
The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This 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 the cobas e 411 immunoassay analyzer.
CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer.
PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer.
This CalCheck set is an assayed control for use in calibration verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer.
Elecsys Vitamin D total II is a second generation assay by Roche Diagnostics for the in vitro quantitative determination of 25-hydroxyvitamin D in human serum and plasma. It is intended for use on the cobas e 411 immunoassay analyzer. The cobas e family of analyzers employs the electrochemiluminescence "ECLIA" technology. The assay is a 27 minute assay utilizing a competition principle and a pretreatment step to release the bound 25-hydroxyvitamin D from the vitamin D binding protein.
Results are determined via a calibration curve which is instrument specifically generated by 2-point calibration against the master curve for that reagent lot.
The provided text describes the acceptance criteria and study proving the device meets those criteria for the Elecsys Vitamin D total II assay and its associated calibrators and controls.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in terms of specific thresholds for performance metrics. Instead, it describes various studies conducted to demonstrate performance and states that the data supports substantial equivalence. The "reported device performance" is woven throughout Section 4, "Non-Clinical Performance Evaluation," and Section 5, "External (Clinical) Testing."
However, we can infer some performance metrics and the studies that support them. The core of the device's acceptable performance is its substantial equivalence to a predicate device (Elecsys Vitamin D Assay K113546) and its traceability to a reference measurement procedure (ID-LC-MS/MS traceable to NIST SRM 2972).
Here's a table summarizing performance aspects:
| Performance Metric | Acceptance Criteria (Inferred/Implied) | Reported Device Performance (Elecsys Vitamin D total II) |
|---|---|---|
| Precision | Demonstrated acceptable repeatability and intermediate precision. | Precision study conducted per CLSI guideline EP5-A3. (Detailed results for mean, SD, and CV at various concentrations are provided in Table 1 under "Precision" for both repeatability and intermediate precision, showing performance comparable to or better than the predicate for the tested analyte levels and concentration ranges.) Example (Repeatability HS1): Mean 11.1 ng/mL, SD 0.725 ng/mL, CV 6.6%. Example (Intermediate HS1): Mean 11.1 ng/mL, SD 0.965 ng/mL, CV 8.7%. |
| Analytical Sensitivity | LoB, LoD, LoQ established and deemed acceptable. | LoB: 2 ng/mL (Same as predicate) |
| LoD: 3 ng/mL (Same as predicate) | ||
| LoQ: 5 ng/mL (Same as predicate) | ||
| Linearity/Reportable Range | Demonstrated linearity across the claimed measuring range. | Claimed measuring range: 5 - 100 ng/mL (Predicate: 5 - 60 ng/mL). Linearity study conducted according to CLSI guideline EP6-A using serum and plasma samples. Data analyzed for linear, quadratic, and cubic polynomials. (Specific linearity data not tabulated, but reported as successfully demonstrated.) |
| High Dose Hook Effect | No significant hook effect within relevant concentrations. | Assessed on cobas e 411 analyzer. "The hook concentration reported corresponds to the highest analyte concentration that generates a signal within the primary measuring range of the assay." (Implies no issue within the measuring range.) |
| Interferences | Limited interference from endogenous substances and common drugs. | HAMA: Assessed, recovery calculated. (Implied acceptable performance since no issues reported.) |
| Endogenous: Hemolysis (≤ 600 mg/dL), Bilirubin (≤ 66 mg/dL), Lipemia/Intralipid (≤ 300 mg/dL), Biotin (≤ 30 ng/mL), Serum albumin (≤ 7 g/dL), Cholesterol (≤ 300 mg/dL), Triglyceride (≤ 300 mg/dL), Rheumatoid Factor ( |
§ 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.