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MAGLUMI 2000 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D in human serum using Maglumi 2000 Fully-auto chemiluminescence immunoassay analyzer. The measurement of 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency.

MAGLUMI 2000 25-OH VITAMIN D kit consists of the following reagents: Magnetic Microbeads- coated with 25-OH Vitamin D monoclonal antibody, containing BSA, NaN3 (

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes a series of analytical performance studies and a method comparison study to demonstrate the performance characteristics of the MAGLUMI 2000 25-OH Vitamin D assay.

2. Sample Sizes and Data Provenance

• Test Set (for specific performance characteristics):

  • Precision: 240 samples per level across 9 sample types (3 controls, 2 calibrators, 3 spiked serum pools, 3 native serum pools). Total N = 240 * 9 = 2160 individual measurements (though some are duplicates/runs, the total 'data points' are numerous).
  • Linearity: 11 levels of linearity samples, each measured in quadruplicate, on 3 lots of reagent.
  • Detection Limit:
    • LOB: 60 measurements of 25-OH VITAMIN D depleted serum samples using 3 different lots of reagents over 5 days.
    • LOD: 4 levels of low samples measured in 60 replicates over 5 days per sample using 3 lots of reagents.
    • LOQ: Six low serum samples, in six replicates per run, one run per day, over 5 days, using 3 lots of reagents.
  • Interference (Cross-reactivity): Used two base serum samples (30 ng/mL and 60 ng/mL total 25-OH VD) spiked with various cross-reactants, measured using 3 lots of reagents.
  • Interference (Endogenous Substances & Common Drugs): Three serum samples (20, 30, and 60 ng/mL 25-OH VITAMIN D) analyzed for each substance.
  • Interference (HAMA, RF, Total Protein): Human serum samples supplemented with potential interferents, tested using 3 lots of reagents.
  • Method Comparison: 241 human serum samples.

• Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It uses "human serum samples" and "patient serum pools." The studies appear to be retrospective in nature, using collected serum samples.

3. Number of Experts and Qualifications for Ground Truth

• This device is an in vitro diagnostic immunoassay. The concept of "ground truth" established by experts (like radiologists for imaging) is not applicable in the same way. The ground truth for such assays is typically established by:

  • Known concentrations for controls and calibrators, often traceable to reference materials (e.g., NIST RMP 2972 for traceability as mentioned).
  • Spiking studies where a known amount of analyte is added to a sample.
  • Comparison to a legally marketed predicate device, which itself has an established ground truth.
  • Pathology/biochemical analysis where the exact concentration of the analyte is determined by highly accurate reference methods (e.g., ID-LC-MS/MS).

  Therefore, there were no human experts establishing the ground truth in the context of clinical interpretation, but rather a robust analytical process to define true concentrations.

4. Adjudication Method for the Test Set

• Not applicable for this type of in vitro diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used in clinical trial settings where human interpretation or consensus for a diagnosis is required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices (often imaging AI) where multiple human readers interpret cases and their performance is compared with and without AI assistance. The MAGLUMI 2000 25-OH Vitamin D is an automated immunoassay, not a device requiring human interpretation in this manner.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance was done. The entire analytical performance section (Precision, Linearity, Stability, Detection Limit, Interference) directly assesses the algorithm's (the immunoassay's) performance without human intervention in the measurement process. The "MAGLUMI 2000 Fully-auto chemiluminescence immunoassay analyzer" is an automated system, meaning the results are generated directly by the device. The method comparison study is also a standalone assessment of the device's output against a predicate.

7. Type of Ground Truth Used

• The ground truth for the analytical validation aspects (e.g., calibrators, controls, linearity samples) is based on pre-defined concentrations, often traceable to reference methods like ID-LC-MS/MS (Isotope Dilution Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) and reference materials such as NIST RMP 2972.
• For interference studies, the "ground truth" is inferred by the known addition of interferents and measuring the deviation from the expected value.

8. Sample Size for the Training Set

• The document does not mention a training set in the context of machine learning or AI. This device is an immunoassay, which functions based on established biochemical principles and reagents, not on a machine learning model that requires a separate training set. The "development" or "optimization" of the assay would involve various experiments, but not a formally defined "training set" like in AI/ML validation.

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

• Not applicable, as there is no mention of a training set for an AI/ML model for this immunoassay.

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