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The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.

The MAGLUMI 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer, and the assay is used for an aid in assessment of vitamin D sufficiency.

MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer:

The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a fully automated instrument system designed to perform in vitro diagnostic tests on clinical specimens. The system utilizes chemiluminescent technology and uses pre-packaged reagent packs for qualitative or quantitative analysis of the analytes in human samples. The analyzer performs automatic sample pipetting, reagent loading, incubation, washing, measurements, and result calculations.

MAGLUMI 25-OH Vitamin D assay:

MAGLUMI 25-OH Vitamin D kit consists of the following reagents:

Magnetic Microbeads- coated with anti-25-OH VD antibody in PBS buffer, NaN3 (

The provided text describes the performance characteristics of the MAGLUMI 25-OH Vitamin D assay and MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer as part of a 510(k) summary for FDA clearance. The information focuses on analytical performance rather than clinical validation with human-in-the-loop studies.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of predefined acceptance criteria. Instead, it reports the analytical performance of the device, which implicitly demonstrates that the device meets some internal or expected performance metrics for an in vitro diagnostic device. The performance data is presented in the "11. Performance Characteristics" section.

Here's an approximation of an acceptance criteria table based on the reported performance, assuming the reported values are the achieved performance that meets internal criteria for release:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Study:

  • Sample Size: 240 measurements per material (two controls, two calibrators, one spiked patient serum pool, three native patient sample pools) across three instruments. Each measurement was taken in duplicate, with 2 runs per day over 20 days.
  • Data Provenance: Not explicitly stated, but common practice for IVD analytical studies focuses on sample types and analytical conditions, not patient demographics or geo-location beyond what's relevant to endogenous interferents. The samples include "patient serum pool" and "native serum pool," implying human biological samples.

• Linearity Study:

  • Sample Size: Eleven linearity samples, each measured in quadruplicate on 3 lots of reagent.
  • Data Provenance: Samples prepared by blending "a low serum sample pool and a high serum sample pool," implying human serum. No country of origin specified.

• Detection Limit Study:

  • LOB: 60 measurements of 25-OH Vitamin D depleted serum samples using 3 different lots of reagents over 3 days.
  • LOD: Four levels of low samples, each measured in 60 replicates over 3 days per sample using 3 lots of reagents.
  • LOQ: Six low serum samples, in five replicates per run, one run per day, over 3 days, using 3 lots of reagents.
  • Data Provenance: "Serum samples," "low serum samples," implying human serum. No country of origin specified.

• Interference Study:

  • Sample Size: Three base serum samples (10, 50, 100 ng/mL 25-OH VD) for endogenous substances and common drugs; human serum samples for HAMA, RF, total protein.
  • Data Provenance: "Human serum pools" and "human serum samples." No country of origin specified.

• Method Comparison Study:

  • Sample Size: 329 native, single donor patient serum samples (121 male, 208 female, age 7 to 98 years).
  • Data Provenance: "Human serum samples." No country of origin specified explicitly, but this is typically retrospective collection of de-identified clinical samples.

• Reference Range Study:

  • Sample Size: 312 serum samples from normal, apparently healthy adult (21 years and older) individuals (181 males, 131 females).
  • Data Provenance: Samples collected from three regions (Central, Southeast and Northeast) in the US. This specifies the country of origin (USA) and regional distribution. This would be considered retrospective.

• Matrix Comparison Study:

  • Sample Size: 78 serum/plasma pairs from the same donor.
  • Data Provenance: "Samples drawn into serum and plasma collection tubes," "from the same donor." No country of origin specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document describes an In Vitro Diagnostic (IVD) device, specifically a quantitative immunoassay. For such devices, "ground truth" is typically established by:

• Reference methods (e.g., LC-MS/MS for Vitamin D, which is considered a gold standard).
• Master Lot/Calibrator values.
• Comparison to a legally marketed predicate device (as done in the "Comparison Studies" section).

There is no mention of human experts (like radiologists) establishing ground truth for individual samples in this context. The "ground truth" in this analytical study is the quantitative concentration of 25-OH Vitamin D as determined by reference materials, calibrators, or the established predicate method.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving qualitative or semi-quantitative assessments (e.g., image-based diagnosis) where multiple human readers interpret data, and discrepancies need to be resolved. This document pertains to the analytical performance of a quantitative immunoassay analyzer, where the output is a numerical concentration.

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

Not applicable. This device is an automated immunoassay analyzer for a quantitative biomarker (25-OH Vitamin D). It is not an AI-assisted diagnostic tool that aids human readers in interpreting complex data like medical images. Therefore, an MRMC study or AI assistance is not relevant to its stated purpose or performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is inherently a "standalone" system in an analytical sense. The MAGLUMI X3 analyzer and the MAGLUMI 25-OH Vitamin D assay perform the quantitative determination automatically. The performance characteristics (precision, linearity, detection limit, interference, method comparison) are all tests of the algorithm's performance (i.e., the instrument and reagent system) without human interpretation affecting the result generation process itself. Clinical interpretation of the numerical results (e.g., patient has vitamin D deficiency based on the number) happens downstream by a clinician, but the device performance itself is standalone.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the analytical performance:

• Precision, Linearity, Detection Limit, Interference: Ground truth is established by the known concentrations of controls, calibrators, spiked samples, and highly characterized depleted/low concentration samples. The "truth" is the intended/expected concentration as determined by a highly accurate measurement or formulation.
• Method Comparison: The predicate device, MAGLUMI 2000 25-OH Vitamin D assay manufactured by SNIBE, served as the comparative "truth" or reference. The study measures agreement between the new device and the predicate. It states "Comparison of the MAGLUMI 25-OH Vitamin D assay (y) with the predicate device, MAGLUMI 2000 25-OH Vitamin D assay (x)."
• Reference Range: Established from empirically tested healthy individuals.

8. The sample size for the training set

This document describes the validation of an immunoassay kit and analyzer, not a machine learning or AI model that requires a "training set" in the computational sense. The "training" for such a system refers to the development and optimization of the chemical reagents, assay protocol, and instrument calibration algorithms by the manufacturer during product development, prior to the validation studies described here. The document does not provide details on the sample sizes or data used during this internal "training" or development phase.

9. How the ground truth for the training set was established

As noted above, "training set" is not applicable in the context of a traditional immunoassay system validation as described here. The "ground truth" for the development and optimization of the assay would typically involve:

• Certified Reference Materials (CRMs): Substances with accurately known concentrations of the analyte, often traceable to international standards.
• Internal Reference Materials: Carefully prepared and validated in-house samples.
• Established Reference Methods: Highly accurate and precise methods (e.g., LC-MS/MS) used to characterize samples during development.
• Cross-validation with existing, well-characterized methods/platforms.

These elements guide the chemical formulation, antibody selection, and instrument parameter setting during the development phase.

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