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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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MAGLUMI 2000 HCG/S-HCG is an in vitro chemiluminescence immunoassay for the quantitative determination of total beta human chorionic gonadotropin (total ß-hCG) in human serum. The measurement of total ß-hCG is used as an aid in the early detection of pregnancy.

MAGLUMI 2000 HCG/B-HCG kit consists of the following reagents: Magnetic Microbeads- coated with anti-HCG monoclonal antibody, containing BSA, NaN3 (

The provided text describes the performance characteristics of the MAGLUMI 2000 HCG/ß-HCG device, an in vitro chemiluminescence immunoassay for the quantitative determination of total beta human chorionic gonadotropin (total ß-hCG) in human serum. This information is presented as part of a 510(k) summary submitted to the FDA. While the document outlines various analytical performance studies, it does not explicitly define acceptance criteria in a quantitative table or refer to a multi-reader multi-case (MRMC) comparative effectiveness study.

However, we can infer acceptance based on the reported performance results aligning with standard clinical laboratory expectations and the successful substantial equivalence determination by the FDA. The study focuses on analytical performance characteristics rather than diagnostic accuracy involving human interpretation of results.

Here's an attempt to structure the information based on your request, identifying what is and isn't available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria. Instead, it describes performance characteristics and indicates compliance with CLSI guidelines. We can infer the "acceptance" derived from the presented data and the overall conclusion of substantial equivalence.

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

• Precision Study: 80 samples analyzed per level (Control 1, Control 2, Control 3, Calibrator Low, Calibrator High, and 6 Native Serum Pools) on each of three instruments. Total N=240 samples per level across three instruments.
• Linearity Study: Linearity samples prepared by mixing high and low level samples. Each sample was measured in quadruple on 3 lots of reagent. The exact number of distinct linearity samples (different concentrations) is not specified, but the range is 0.3 to 4680 mIU/mL.
• Detection Limit Studies:
  • LOB: 80 measurements of HCG/ß-HCG negative serum samples using 3 different lots over 5 days.
  • LOD: Four levels of low samples, measured in 80 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 Study: Two base serum samples (6.0 mIU/mL and 100 mIU/mL HCG/ß-HCG) spiked with various cross-reactants. Also, human serum pools with 6.0 mIU/mL, 100 mIU/mL, and 2000 mIU/mL HCG/ß-HCG for endogenous substances and common drugs. Each tested using 3 lots of reagents. Exact number of distinct interferent samples not specified.
• Hook Effect: Six samples with HCG/ß-HCG concentrations from 5000 to 1,000,000 mIU/mL prepared by spiking. Serial dilutions tested using 3 different lots.
• On-board Dilution Recovery: Twelve serum samples with HCG/ß-HCG concentrations from 4475 to 223750 mIU/mL tested using three reagent lots and three instruments.
• Method Comparison Study: 201 human serum samples with concentrations ranging from 1.1 to 4934 mIU/mL (as determined by the predicate device).
• Expected Values/Reference Range: 431 serum samples from non-pregnant, apparently healthy females (20 years and older).

Data Provenance: The document does not explicitly state the country of origin for the data. Given the submitter's location (Shenzhen, China) and the FDA submission, it's likely the studies were conducted in China or involved samples from that region, but this is not explicitly confirmed. The studies are described in a manner typical of prospective performance evaluation studies for an in vitro diagnostic device, rather than retrospective analysis of pre-existing data.

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

This type of information is not applicable to this submission. The device is an in vitro diagnostic immunoassay for quantitative measurement of a biomarker (hCG). Ground truth is established by the reference measurement procedure of the MAGLUMI 2000 instrument itself and validated through analytical performance studies (precision, linearity, detection limits, method comparison to a legally marketed predicate device, etc.) rather than through expert human interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As the device is an in vitro diagnostic assay providing a quantitative numerical result, there is no human interpretation or subjective assessment that would require an adjudication method. The "ground truth" for method comparison is the value obtained from the predicate device. For analytical performance studies, it's the objectively measured values and their statistical distributions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is typically conducted for image-based diagnostic aids (e.g., AI for radiology) where human readers interpret medical images. This device is a lab-based immunoassay that provides a quantitative numerical result. Therefore, an MRMC study is not relevant or applicable.

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

Yes, the entire study is essentially a standalone performance evaluation. The MAGLUMI 2000 HCG/ß-HCG is an automated chemiluminescence immunoassay system. Its performance characteristics (precision, linearity, detection limits, interference, hook effect, dilution recovery, and method comparison) are evaluated as the direct output of the instrument and its reagents, without explicit human interpretation being part of the device's function or the primary subject of these studies. The quantitative output of the device itself constitutes its "performance."

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is established through:

• Reference Measurement Procedures/Known Concentrations: For studies like linearity, detection limits, and interference, known concentrations or "spiked" samples are used as a reference.
• Measurement against a Predicate Device: For the method comparison study, the results from the Beckman Access Total B-HCG (5th IS) Assay (the predicate device) served as the comparative "ground truth" to establish substantial equivalence.
• Statistical Analysis of Replicate Measurements: For precision, the statistical variation around the mean measured value for controls and patient samples provides the "ground truth" of the device's reproducibility.
• Physiological/Clinical Samples: For determining expected values/reference ranges, samples from apparently healthy individuals are used.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of an algorithm or machine learning model. This is an in vitro diagnostic assay, not an AI/ML-based device that typically undergoes a distinct training/validation/test split of data. The studies described are analytical verification and validation studies in a traditional medical device development sense.

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

Not applicable. As there is no defined "training set" for an AI/ML algorithm, this question is not relevant to the described device and its evaluation. The "training" of such a system would involve the manufacturer's internal assay development and optimization, which isn't part of a regulatory submission summary like this.

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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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The MAGLUMI 2000 FT4 assay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in human serum. The measurement of FT4 is used in the diagnosis of thyroid disorders.

MAGLUMI 2000 FT4 kit consists of the following reagents: Magnetic Microbeads- coated with T4 antigen, BSA, NaN3(

Here's an analysis of the acceptance criteria and study findings for the MAGLUMI 2000 FT4 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document often refers to CLSI guidelines (e.g., EP5-A2, EP6-A, EP17-A, EP9-A2) for performance characteristic studies. While explicit numerical acceptance criteria are not always stated directly in the text, compliance with these guidelines implicitly means that the performance falls within industry-accepted ranges and statistical thresholds. For precision, for instance, a total CV of less than 10% (or even lower for higher concentrations) is generally considered acceptable in clinical chemistry. For linearity and method comparison, an R² value close to 1, a slope near 1, and a y-intercept near 0 are standard indicators of good performance.

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

• Precision Study:
  • Sample Size: 240 measurements per control/calibrator/pool (N=240, from 80 samples analyzed per level on each of 3 instruments).
  • Data Provenance: Not explicitly stated, but implied to be patient serum pools and native patient samples from clinical settings, likely domestic to the manufacturer's testing location or within industry standard practices for clinical evaluation. The study was conducted on "three controls, two calibrators, four spiked patient serum pools and four native patient sample pools."
• Linearity Study:
  • Sample Size: 11 levels with FT4 concentrations from 0.19 to 10.0 ng/dL, each measured in quadruplicate on 3 lots of reagent.
  • Data Provenance: Samples prepared by spiking T4 USP Standard into T4-free human serum samples.
• Detection Limit Study (LOB, LOD, LOQ):
  • LOB: 80 measurements of T4 free human serum samples.
  • LOD: Four levels of low samples, measured in 80 replicates over 5 days per sample.
  • LOQ: Six low serum samples, in six replicates per run, one run per day, over 5 days.
  • Data Provenance: T4 free human serum samples and low serum samples.
• Interference Study:
  • Sample Size: Variable, involves preparing solutions, and for common drugs/interfering substances, three serum samples (low, medium, high FT4) per substance. For HAMA/RF/Protein, specific FT4 human serum samples.
  • Data Provenance: Spiked solutions, human serum pools, FT4 human serum samples.
• Method Comparison Study:
  • Sample Size: 224 human serum samples.
  • Data Provenance: Human serum samples. Provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated.
• Expected Values/Reference Range Study:
  • Sample Size: 157 serum samples.
  • Data Provenance: Normal, apparently healthy adult individuals (22 years and older). Provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated.

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

This information is not provided in the document. For an in vitro diagnostic device like the MAGLUMI 2000 FT4, the "ground truth" for analytical performance tests (precision, linearity, detection limits, interference) is typically established by the reference methods, spiked concentrations, or consensus values derived from the testing procedures themselves, rather than human expert opinion. For method comparison, the "ground truth" is typically the result from the established predicate device.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1 for clinical diagnoses based on expert review) is not applicable to the analytical performance studies described for this in vitro diagnostic device. The studies rely on quantitative measurements and statistical analysis rather than subjective expert interpretation of results for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for medical imaging devices or other diagnostic tools where human readers interpret results, and the AI system acts as an aid to improve human performance. For an automated in vitro diagnostic assay like MAGLUMI 2000 FT4, the performance is evaluated through direct analytical comparisons.

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

Yes, the studies described are for the standalone performance of the MAGLUMI 2000 FT4 device. These are analytical performance studies (precision, linearity, detection limits, interference, method comparison) that evaluate the device's ability to accurately and precisely measure FT4 concentrations in human serum, independent of human interpretation or intervention in the measurement process itself. The "algorithm" here refers to the immunoassay's chemistries and the instrument's measurement principles.

7. The Type of Ground Truth Used

• Precision: Reference materials (controls, calibrators) with established target values, and pooled human serum samples where the mean serves as a statistical "ground truth" for variability assessment.
• Linearity: Gravimetrically or volumetrically prepared "expected" concentrations of T4 in serum.
• Stability: Initial measurements at time 0, with subsequent measurements compared to these baselines.
• Detection Limits (LOB, LOD, LOQ): Analyte-free samples and low-concentration samples measured extensively to statistically determine minimum detectable/quantifiable levels.
• Interference (Cross-Reactivity): Known amounts of potential interferents/cross-reactants.
• Method Comparison: Results from the predicate device (Siemens ADVIA Centaur FT4) are used as the reference "ground truth" for comparison.
• Expected Values/Reference Range: Statistical distribution of measurements from a reference population (157 apparently healthy adults) to establish a normal range.

8. The Sample Size for the Training Set

This information is not provided. The document describes performance characteristic studies (test set), but does not detail the development or "training" specific to an AI algorithm for this device. For in vitro diagnostics, "training set" would typically refer to samples used during the assay development and optimization phase to establish parameters like calibration curves, reagent formulations, or instrument settings. The document focuses on validation studies.

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

This information is not provided as a "training set" isn't explicitly defined in the context of this submission. If referring to the development/optimization phase of a typical immunoassay, ground truth would be established through:

• Reference materials: Highly purified FT4 standards.
• Known concentrations: Samples prepared with precise, known concentrations of FT4.
• Comparative data: Initial comparisons against existing reference methods or well-characterized assays during the research and development phase.
• Clinical samples: Use of a large number of clinical samples to optimize the assay's dynamic range and specificity.

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The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum. The measurement of TSH is used in the diagnosis of thyroid disorders.

The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system's assay application utilizes chemiluminescents technology for clinical use.

The MAGLUMI 2000 system is a floor model, fully automated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software.

MAGLUMI 2000 TSH kit consists of the following reagents: Magnetic Microbeads- coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(

The provided text describes the performance characteristics of the MAGLUMI 2000 TSH assay and MAGLUMI 2000 Immunoassay Analyzer. Below is an attempt to extract and organize the information as requested, though some categories may not be fully addressed due to the nature of the document (a 510(k) summary for a diagnostic test, not an AI-powered device).

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

The document does not explicitly state "acceptance criteria" in a table format alongside device performance for all aspects. However, performance characteristics are presented, from which implied acceptance ranges can be inferred (e.g., for precision, interference, and linearity). The comparison study shows the performance relative to a predicate device.

• Conjugate Bilirubin (60 mg/dL)
• Hemoglobin (2000 mg/dL)
• Triglycerides (1000 mg/dL)
• Acetaminophen (20 mg/dL)
• Ibuprofen (50 mg/dL)
• Aspirin (50 mg/dL)
• Biotin (10 ng/mL)
• Unconjugate bilirubin (40 mg/dL)
• Rheumatoid factor (124 IU/mL)
• Human anti-mouse antibodies (HAMA) (300 ng/mL)
• Total protein (12.5 mg/mL) |
  | Specificity (Cross-reactivity) | Low cross-reactivity with structurally related hormones. | Less than 2% cross-reactivity with hCG (200 IU/mL), FSH (1500 mIU/mL), and LH (600 mIU/mL). |
  | Method Comparison | Good correlation with predicate device. | Correlation with ADVIA CENTAUR TSH assay: Y = 1.0178X - 0.0773, R² = 0.9974 (for TSH values 0.02 - 91.78 uIU/mL) |
  | Expected Values/Reference Range | Establishment of a normal range for the intended population. | Normal Range: 0.658 – 4.864 µIU/mL (based on 126 healthy adult samples, central 95% frequency distribution). |
  | Stability (Reagents) | Stable for specified duration under given conditions. | Accelerated Stability (Controls, Calibrators): 12 months at 2-8°C.
  Shelf Life Stability (Reagent Kit): 12 months at 2-8°C.
  Open Kit Stability: 4 weeks at 2-8°C. |
  | Traceability | Traceable to an international standard. | Traceable to the WHO international standard for human TSH (IRP 81/565) for controls and calibrators. |

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

• Precision Study:
  • Sample Size: 4 controls, 2 calibrators, 6 spiked patient serum pools, and 4 native patient sample pools. Each level analyzed 80 times (20 days x 2 runs/day x duplicate) per instrument. (Total N = 240 samples per level across 3 instruments for calculated statistics in the table).
  • Data Provenance: Not specified (e.g., country of origin). The study design (e.g., "collected over 20 days") suggests prospective testing during the assay development/validation phase.
• Linearity Study:
  • Sample Size: 2 primary samples to create a series of intermediate serum dilutions (number of intermediate dilutions not explicitly stated, but 11 data points shown in the table).
  • Data Provenance: Not specified.
• Detection Limit Study:
  • Sample Size: Not explicitly stated, derived from CLSI EP17-A guidelines.
  • Data Provenance: Not specified.
• Interference Study:
  • Sample Size: Human serum samples with low and high TSH concentrations were used for each interfering substance (e.g., "0.97 and 5.4" or "0.7 and 6.1" µIU/mL). The number of individual samples is not described, but it involved at least two TSH concentrations for each interferent.
  • Data Provenance: Not specified.
• Specificity Study:
  • Sample Size: Human serum samples with various TSH concentrations (number not specified) spiked with potential cross-reactants.
  • Data Provenance: Not specified.
• Comparison Studies:
  • Sample Size: 337 patient serum samples.
  • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
• Expected Values/Reference Range:
  • Sample Size: 126 serum samples.
  • Data Provenance: From "normal, apparently healthy adult (22 years and older) individuals." Not specified (e.g., country of origin, retrospective or prospective).

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 is a diagnostic assay for a biomarker (TSH), not an image-based AI device requiring expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" for the test sets (e.g., precision, linearity, interference) is based on the known concentrations of controls, calibrators, spiked samples, or comparison to a predicate device.

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

Not applicable. As a diagnostic assay, "adjudication" in the sense of reconciling divergent expert opinions on an output is not relevant. The performance studies evaluate the assay's analytical characteristics against established scientific protocols and reference methods.

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 document describes a diagnostic immunoassay system, not an AI-assisted diagnostic tool requiring human readability.

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

The device itself is an automated immunoassay system (MAGLUMI 2000 Immunoassay Analyzer) performing the quantitative determination of TSH using a specific assay (MAGLUMI 2000 TSH assay). Its performance is inherently "standalone" in that it produces a quantitative result from a sample without human interpretive intervention post-assay. The results are then interpreted by clinicians.

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

The ground truth for the analytical performance studies (precision, linearity, detection limits, interference, specificity) is primarily based on:

• Known concentrations: For controls, calibrators, and spiked samples.
• Comparison to a legally marketed predicate device: For method comparison (ADVIA CENTAUR TSH assay).
• International standards: Traceability to WHO international standard for human TSH (IRP 81/565).
• Established scientific protocols: CLSI guidelines.

8. The sample size for the training set

This document describes the validation of a diagnostic immunoassay system, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The performance studies detailed are for validation.

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

Not applicable, as there is no "training set" for an AI algorithm.

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