(244 days)
The IDS-iSYS 1,25 Dihydroxy Vitamin D assay is intended for the determination of 1,25 dihydroxyvitamin D levels in serum and plasma on the IDS-iSYS Multi-Discipline Automated System. Results of the 1.25 Dihydroxy Vitamin D are used in the assessment of vitamin D sufficiency.
The IDS-iSYS 1,25 Dihydroxy Vitamin D Control Set is used for quality control of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay on the IDS-iSYS Multi-Discipline Automated System
The IDS-iSYS 1,25 Dihydroxy Vitamin D Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
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Acceptance Criteria and Study for IDS iSYS 1,25 Dihydroxy Vitamin D Assay
Based on the provided document (K123253), the device in question is the IDS iSYS 1,25 Dihydroxy Vitamin D assay. This type of device is a diagnostic assay, and as such, its performance is typically evaluated based on analytical characteristics like precision, accuracy, linearity, and interference. The document itself is a 510(k) clearance letter, which indicates substantial equivalence to a predicate device. It doesn't contain the full study reports with detailed acceptance criteria and performance data.
However, based on typical FDA requirements for in vitro diagnostic assays and the context of a 510(k) submission for a Vitamin D test system, we can infer and describe the likely acceptance criteria and the nature of studies performed. This will be a reconstruction of what would typically be included in the full submission, as the provided document is merely the FDA's clearance letter.
1. Table of Acceptance Criteria and the Reported Device Performance
Since the detailed study results are not in the provided document, the "Reported Device Performance" here refers to the outcomes that would have led to a substantial equivalence determination for an assay. The acceptance criteria are typical for a diagnostic immunoassay.
| Performance Characteristic | Acceptance Criteria (Typical for Immunoassays) | Reported Device Performance (Inferred from 510(k) Clearance) |
|---|---|---|
| Precision (Repeatability) | %CV ≤ 10% within-run, %CV ≤ 15% total | Met acceptance criteria for various concentrations. |
| Accuracy (Bias/Comparison to Predicate) | Correlation coefficient (r) ≥ 0.95 and/or acceptable bias vs. predicate device. | Demonstrated substantial equivalence to the predicate device, indicating acceptable correlation and bias. |
| Linearity | Measured values within +/- X% of expected values across the assay range. | Demonstrated linearity across the claimed measuring range. |
| Analytical Measurement Range (AMR) | Established range where linearity and accuracy are maintained. | Established and verified, typically covering clinically relevant levels. |
| Limit of Detection (LoD) | LoD ≤ X ng/mL (specific to analyte and clinical need) | Established LoD, indicating the lowest detectable concentration. |
| Limit of Quantitation (LoQ) | LoQ ≤ Y ng/mL (specific to analyte, with acceptable precision) | Established LoQ, indicating the lowest quantifiable concentration with acceptable precision. |
| Interference | No significant interference (e.g., |
§ 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.