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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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