(265 days)
The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.
The ARCHITECT 25-OH Vitamin D Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of 25-hvdroxyvitamin D (25-OH Vitamin D) in human serum and plasma.
The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of 25-hydroxyvitamin D (25-OH Vitamin D) in human serum and plasma.
For in vitro diagnostic use.
Prescription Use
The ARCHITECT 25-OH Vitamin D assay is a delayed one-step immunoassay including a sample pre-treatment for the quantitative determination of vitamin D in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.
Sample and pre-treatment reagent are combined. An aliquot of the pre-treated sample is combined with assay dijuent and paramagnetic anti-vitamin D coated microparticles to create a reaction mixture. Vitamin D present in the sample binds to anti-vitamin D coated microparticles. After incubation a biotinylated vitamin D anti-Biotin acridinium-labeled conjugate complex is added to the reaction mixture and binds to unoccupied binding sites of the anti-vitamin D coated microparticles. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vitamin D in the sample and the RLUs detected by the ARCHITECT i System optics.
The provided 510(k) summary for the ARCHITECT 25-OH Vitamin D assay focuses on demonstrating substantial equivalence to a predicate device rather than establishing comprehensive acceptance criteria with specific thresholds for performance metrics.
Here's an analysis of the available information structured to address your points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (LIAISON® 25 OH Vitamin D TOTAL) in terms of Precision, Linearity, and Interferences | Precision: Substantially equivalent to predicate. |
| Linearity: Substantially equivalent to predicate. | |
| Interferences: Substantially equivalent to predicate. | |
| Correlation with Predicate Device | Correlation Coefficient: 0.93 |
| Slope of Regression Analysis (vs. Predicate) | Slope: 0.97 |
| Intercept of Regression Analysis (vs. Predicate) | Intercept: -1.07 |
Note: The document states that the ARCHITECT 25-OH Vitamin D assay is "substantially equivalent to the LIAISON® 25 OH Vitamin D TOTAL assay in terms of precision, linearity and interferences." However, specific numerical acceptance criteria (e.g., precision CV%
§ 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.