(154 days)
The LIAISON® 25 OH Vitamin D Assay uses chemiluminescent immunoassay (CLIA) technology intended for the quantitative determination of 25hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be 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 an adult population
The method for quantitative determination of 25 OH Vitamin D is a direct, competitive chemiluminescence immunoassay (CLIA). Specific antibody to Vitamin D is used for coating magnetic particles (solid phase) and Vitamin D is linked to an isoluminol derivative. During the incubation, 25 OH Vitamin D is dissociated from its binding protein, and competes with labeled Vitamin D for binding sites on the antibody. After the incubation, the unbound material is removed with a wash cycle, Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of 25 OH Vitamin D present in calibrators, controls, or samples.
The provided text describes the LIAISON® 25 OH Vitamin D Assay, a chemiluminescent immunoassay for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied / Expected) | Reported Device Performance (LIAISON® 25 OH Vitamin D Assay) |
|---|---|---|
| Sensitivity (analytical) | Low |
§ 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.