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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.

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1. Table of Acceptance Criteria and Reported Device Performance

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%

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