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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.

Here's an analysis of the available information structured to address your points:

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% < X%, linearity within Y% deviation) are not explicitly defined in this summary. The reported performance is primarily presented as the correlation with the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the sample collection).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this submission, as the "ground truth" for evaluating the ARCHITECT 25-OH Vitamin D assay's performance is based on its correlation with a legally marketed predicate device (LIAISON® 25 OH Vitamin D TOTAL), not on expert consensus or interpretation of images/data. The predicate device's results serve as the reference.

4. Adjudication Method for the Test Set

This is not applicable. As stated above, the evaluation relies on a comparison to a predicate device, not on expert adjudication of a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. The ARCHITECT 25-OH Vitamin D assay is an in vitro diagnostic (IVD) immunoassay for quantitative determination of a biomarker. It is not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, the study described is a standalone performance study of the ARCHITECT 25-OH Vitamin D assay. It evaluates the device's analytical performance on its own, comparing its results to a predicate device. There is no "human-in-the-loop" component in the assay's function.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) used for evaluating the ARCHITECT 25-OH Vitamin D assay's performance was the results obtained from the LIAISON® 25 OH Vitamin D TOTAL assay. This represents a comparison to a legally marketed, previously cleared device.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For an immunoassay like this, the "training" equivalent would typically involve assay development and optimization using various formulations and reagent concentrations, rather than a distinct "training set" of patient samples in the way an AI algorithm would have. The performance data presented is likely from a validation or testing set.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, a distinct "training set" with established ground truth in the context of an AI algorithm is not directly applicable here. The development and optimization of the immunoassay would have involved internal analytical validation using reference materials and potentially patient samples, with their values determined by established methods or reference assays. However, the document does not detail this process explicitly. The "ground truth" for the performance evaluation described is the predicate device's results.

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