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The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Vitamin D. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum, with each level containing Vitamin D. It is used to confirm the proper calibration, linear operating range, and reportable range of Vitamin D. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

{
  "1": {
    "title": "Acceptance Criteria and Reported Device Performance for Audit® MicroCV™ Vitamin D Linearity Set",
    "table": {
      "headers": [
        "Vitamin D (ng/mL)",
        "Level A",
        "Level B",
        "Level C",
        "Level D",
        "Level E"
      ],
      "rows": [
        [
          "Target value",
          "20.18",
          "46.57",
          "77.68",
          "107.32",
          "135.72"
        ],
        [
          "Target Range",
          "17.15-23.21",
          "39.58-53.55",
          "66.03-89.33",
          "91.22-123.42",
          "115.36-156.08"
        ]
      ]
    },
    "notes": "The provided document specifically details the 'Expected Values' for the Audit® MicroCV™ Vitamin D Linearity Set. These expected values and their target ranges serve as the reported device performance and implicitly, the acceptance criteria for the linearity of the Vitamin D measurements across the five levels (A-E) on the Advia Centaur instrument using Siemens Reagent. The product is intended to demonstrate a linear relationship between these levels."
  },
  "2": "The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions that stability studies and value assignments were performed and that 'All supporting data is retained on file at Aalto Scientific, Ltd.'",
  "3": "The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.",
  "4": "The document does not specify an adjudication method for the test set.",
  "5": "A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a quality control material, not an AI-assisted diagnostic tool for human readers.",
  "6": "A standalone performance study was not explicitly described as 'algorithm only without human-in-the-loop performance'. The context is a quality control material for an instrument, not a standalone algorithm in the typical AI sense.",
  "7": "The type of 'ground truth' for the expected values appears to be established through 'Value assignment' performed by the manufacturer, implying internal testing and validation against established laboratory methods or reference materials. It's described as 'Expected Values' determined for the Audit® MicroCV™ Vitamin D Linearity Set, suggesting a form of expert consensus or manufacturer-defined reference values for the particular instrument/reagent combination.",
  "8": "The document does not specify the sample size for the training set.",
  "9": "The document does not detail how the ground truth for a training set (if applicable) was established. The focus is on establishing expected values and stability for the quality control material itself."
}

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