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Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The Tina-Quant ® IgG Gen.2 is an immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF). Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. The assay contains a standard application for measurement of IgG in human serum and plasma and a sensitive application for measurement of IgG in CSF.

The document describes the Tina-Quant IgG Gen.2 device, an immunoturbidimetric assay for the quantitative determination of IgG in human serum, plasma, and cerebrospinal fluid (CSF). The following information is extracted regarding its acceptance criteria and the study that proves it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the performance characteristics presented. The key performance characteristics are:

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

• Test Set Sample Size:
  • For the Method Comparison study, 54 samples were used for CSF.
  • For Precision, various control sera and human CSF samples were used, with specific concentrations mentioned (e.g., 11.7 mg/L human CSF, 13.21 mg/L human CSF for precision studies). The exact number of samples for each precision test is not explicitly stated as a single total, but rather the results for specific concentrations/controls.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.

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. The studies described are analytical performance studies comparing the new device to a predicate device and assessing within-device performance characteristics, not studies relying on expert ground truth for interpretation of clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable to the type of analytical performance studies described in the document. No adjudication method is mentioned as there were no subjective interpretations requiring consensus.

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

This information is not applicable to the Tina-Quant IgG Gen.2 device, as it is an in vitro diagnostic assay (a chemical analyzer) and not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

The performance data presented (measuring range, precision, sensitivity, method comparison) reflects the standalone performance of the Tina-Quant IgG Gen.2 assay as an automated in vitro diagnostic test. This device does not incorporate a human-in-the-loop component for its primary function of quantitative IgG determination.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies of the Tina-Quant IgG Gen.2 device is established by:

• Traceability/Standardization: To CRM 470, a certified reference material. This provides a universally accepted standard for IgG measurement.
• Comparison to a Legally Marketed Predicate Device: The Dade-Behring N Antisera to Human Immunoglobulins IgG on BN II device, which is already established and accepted in the market.

Therefore, the "ground truth" is based on standardized reference materials and the performance of an established, legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not applicable. The Tina-Quant IgG Gen.2 is a chemical assay, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

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Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The Tina-quant IgG Gen.2 is an immunoturbidimetric assay. Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

This is a request for information about a 510(k) submission for a medical device called "Tina-quant IgG Gen.2". The provided text is a 510(k) summary and the FDA's clearance letter. The document does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The text describes an immunoturbidimetric assay for measuring IgG in human serum and plasma. It compares the new device (Tina-quant IgG Gen.2) to a predicate device (Tina-quant IgG, K955906) and highlights similarities and differences, primarily in measuring range and expected values for different age groups.

Therefore, I cannot provide the requested information based on the input text. The provided document is a regulatory filing, not a scientific study report detailing performance metrics against specific acceptance criteria.

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The Wako IgG II - HA test is an in vitro assay for the quantitative determination of immunoglobulin G in serum.

The Wako IgG II - HA test is an in vitro assay for the quantitative determination of immunoglobulin G in serum. When a sample is mixed with the Buffer solution and Anti-IgG, IgG in the sample combines specifically with anti-human IgG antibody in the Anti-IgG to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgG in the sample.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Wako IgG II-HA test:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the comparison study or the provenance of the data (country of origin, retrospective/prospective). It only mentions "comparison studies against the predicate assay."

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

This information is not provided in the document. The ground truth for this type of in vitro diagnostic device is typically established by comparing its measurements to a widely accepted reference method or a legally marketed predicate device, rather than involving expert human readers for interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the document describes an in vitro diagnostic assay that generates quantitative results, not a device requiring human interpretation and multi-reader adjudication. The comparison is made between the numerical output of the new device and the predicate device.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human interpretation, not for an in vitro diagnostic assay like the Wako IgG II-HA test, which provides a direct quantitative measurement.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance Study

Yes, the study described is a standalone performance study. The core of the evidence is the direct comparison of the Wako IgG II-HA test's quantitative results against those of the predicate device (Wako IgG HA-Direct product). There is no "human-in-the-loop" component for interpretation in this context.

7. Type of Ground Truth Used

The ground truth used for establishing the substantial equivalence of the Wako IgG II-HA test is the measurements obtained from a legally marketed predicate device, the Wako IgG HA-Direct product.

8. Sample Size for the Training Set

The document does not specify a training set size. For an in vitro diagnostic device like this, the "training" (or development and optimization) would typically involve internal validation and optimization of the reagent formulation and assay parameters, rather than a distinct "training set" in the machine learning sense. The comparison study acts more like a validation or test set.

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

Since a "training set" in the machine learning context is not explicitly described, the method for establishing its ground truth is also not provided. The ground truth for the validation against the predicate device would be the results generated by the predicate device itself.

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The K-ASSAY IgG Assay is intended to be used for the quantitative determination of IgG in human serum by immunoturbidimetric assay. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the K-ASSAY IgG device. It acknowledges the device's substantial equivalence to previously marketed devices for the quantitative determination of IgG in human serum.

However, this document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the specific study proving the device meets those criteria. The letter focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study report.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

To obtain this information, you would typically need access to the full 510(k) submission, specifically the performance study report and potentially the validation protocols, which are not included in this FDA clearance letter.

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The Immunoglobulin G assay is used for the quantitation of immunoglobulin G in human serum or plasma. Measurement of immunoglobulin G aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.

{
  "acceptance_criteria_and_performance": {
    "table": [
      {
        "criterion": "Correlation Coefficient",
        "acceptance_criteria": "> 0.99",
        "reported_performance": "0.9966"
      },
      {
        "criterion": "Slope (vs. predicate)",
        "acceptance_criteria": "Close to 1",
        "reported_performance": "0.957"
      },
      {
        "criterion": "Y-intercept (vs. predicate)",
        "acceptance_criteria": "Close to 0",
        "reported_performance": "40.555 mg/dL"
      },
      {
        "criterion": "Total %CV for Level 1/Panel 401 (Precision)",
        "acceptance_criteria": "Low variability",
        "reported_performance": "2.1%"
      },
      {
        "criterion": "Total %CV for Level 2/Panel 402 (Precision)",
        "acceptance_criteria": "Low variability",
        "reported_performance": "1.7%"
      },
      {
        "criterion": "Assay Range",
        "acceptance_criteria": "Clinically relevant range",
        "reported_performance": "21.0 to 6,147.43 mg/dL"
      },
      {
        "criterion": "Limit of Quantitation (Sensitivity)",
        "acceptance_criteria": "Low detection limit",
        "reported_performance": "21.0 mg/dL"
      }
    ],
    "study_description": "Comparative performance studies were conducted using the AEROSET™ System. The Immunoglobulin G assay method comparison yielded acceptable correlation with the Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer. Precision studies were conducted using the Immunoglobulin G assay, including within-run, between-run, and between-day studies using two levels of control material."
  },
  "sample_size_test_set": "Not explicitly stated for comparative performance studies. Precision studies used two levels of control material.",
  "data_provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Studies were conducted using the AEROSET™ System.",
  "number_of_experts_ground_truth": "N/A - This is an in vitro diagnostic assay with a predicate device comparison, not an imaging device requiring expert consensus for ground truth.",
  "qualifications_of_experts": "N/A",
  "adjudication_method": "N/A",
  "mrmc_comparative_effectiveness_study": "No, this is not an MRMC study. This is a substantial equivalence study for an in vitro diagnostic assay comparing performance to a predicate device.",
  "standalone_performance_study": "Yes, standalone performance was assessed through precision studies (within-run, between-run, and between-day variability) and the assay range/sensitivity determination.",
  "type_of_ground_truth_test_set": "The 'ground truth' for the comparative performance study was the results obtained from the predicate device (Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer). For precision and sensitivity, the ground truth is derived from established laboratory methods and control materials.",
  "sample_size_training_set": "Not applicable, as this is an in vitro diagnostic assay not employing machine learning for 'training' in the traditional sense.",
  "ground_truth_for_training_set_established": "Not applicable."
}

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The SYNCHRON LX Systems Immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with dinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Immunoglobulin M (Ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX™ Systems Immunoglobulin G, A, and M (Ig-G, Ig-A, Ig-M) Reagents in conjunction with SYNCHRON LX Calibrator 1, are intended for use on Beckman's SYNCHRON LX Clinical Systems.

The provided 510(k) summary describes the SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The performance data focuses on method comparison, imprecision, and stability studies.

Here's an analysis of the acceptance criteria and study data based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance metrics in a formal, separate table. However, equivalence is demonstrated by comparing the new device's performance to the predicate devices through method comparison studies. The implicit acceptance criteria for method comparison would be a strong correlation (r-value close to 1) and a slope close to 1 with an intercept close to 0, indicating a close agreement with the predicate. For imprecision, lower Coefficients of Variation (CV%) indicate better precision. Stability claims are also presented, which serve as performance claims that must be met.

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The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quartitative determination of Immunoglobulin G in urine by rate nephelometry.

The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in coniunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of Immunoglobulin G in human urine samples.

This document describes the IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) Reagent. The acceptance criteria and supporting study are outlined below:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sized used for the test set and the data provenance:

• Method Comparison Test Set Size: 115 samples.
• Data Provenance: Not specified; the document does not mention the country of origin or if the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is an in-vitro diagnostic device measuring a biological analyte. The ground truth for method comparison is the measurement obtained from a predicate device, not expert consensus.

3. Adjudication method for the test set:

• Not applicable. As this is a quantitative analytical device, adjudication by experts for ground truth is not relevant. The comparison is against a well-established predicate device.

4. 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 is an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool that involves human readers.

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

• Yes, this study represents a standalone performance evaluation of the IMMAGE IGU Reagent system. Its performance is compared to a predicate device, and its stability and imprecision are assessed independently. The "algorithm" here refers to the nephelometric methodology of the IMMAGE system.

6. The type of ground truth used:

• Method Comparison: The ground truth for the method comparison study was established by measurements obtained from the Beckman Immunoglobulin G (IGG) Test System (Urine application), which is the predicate device.
• Stability and Imprecision: The ground truth for stability and imprecision studies would be based on established analytical reference methods and quality control materials for immunoglobulin G measurements.

7. The sample size for the training set:

• Not applicable. This document describes an in-vitro diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development of such reagents relies on chemical and biological principles, not statistical learning from a dataset.

8. How the ground truth for the training set was established:

• Not applicable, as there is no "training set" for this type of device.

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The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry.

The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry.

The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human immunoglobulin M by rate nephelometry.

The IMMAGE Immunochemistry System Immunoglobulins IGG, IGA, and IGM, Reagents in conjunction with Beckman Calibrator 1, are intended for use on Beckman's IMMAGE Immunochemistry System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Beckman IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance metrics like slope, intercept, r, or %C.V. Instead, it presents the results of studies and implies that these results demonstrate "substantial equivalence to chemistry test systems already in commercial distribution."

However, based on the provided data, we can infer the reported performance, which implicitly functions as the evidence for meeting implied acceptance.

• 24 month shelf-life
• 14 day open container stability
• 14 day calibration stability |
  | Within-Run Imprecision| Low Coefficient of Variation (%C.V.) at different analyte levels. | IGG Reagent (Serum):
  Level 1: 549 mg/dL (mean), 10.8 mg/dL (SD), 2.0 %C.V.
  Level 2: 1293 mg/dL (mean), 203 mg/dL (SD)
  Level 3: 2362 mg/dL (mean), 51 mg/dL (SD)
  IGG Reagent (CSF):
  Level 1: 1.62 mg/dL (mean), 0.086 mg/dL (SD), 5.3 %C.V.
  Level 2: 7.85 mg/dL (mean), 0.104 mg/dL (SD), 1.3 %C.V.
  Level 3: 13.5 mg/dL (mean), 0.52 mg/dL (SD), 3.9 %C.V.
  (Incomplete data for IGA and IGM imprecision in the provided text, but the format implies similar data was used.) |

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

• Sample Sizes (Method Comparison):
  • IMMAGE IGG (Serum): 323 samples
  • IMMAGE IGG (CSF): 100 samples
  • IMMAGE IGA (Serum): 289 samples
  • IMMAGE IGM (Serum): 247 samples
• Sample Sizes (Imprecision):
  • IGG (CSF) Levels: 30 samples for each of the 3 levels.
  • The sample size for serum IGG imprecision is not explicitly stated as 'n' is missing from the table although it shows 3 levels of measurement.
  • The sample sizes for IGA and IGM imprecision are not fully provided due to formatting issues in the input.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions serum and CSF sample types.

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

This type of information (expert involvement for ground truth) is not applicable to this device. This is a quantitative diagnostic device that measures immunoglobulin levels. The "ground truth" is established by the performance of the predicate device (Beckman Immunochemistry Systems Reagents) and the inherent chemical/physical properties being measured. There are no human experts "interpreting" results for a ground truth in the way there would be for image-based diagnostic systems.

4. Adjudication Method for the Test Set

This is not applicable to this device. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective assessments, such as expert interpretation of medical images. For a quantitative measurement device, the "ground truth" for comparison is the measurement obtained from the predicate device.

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

This is not applicable to this device. An MRMC study assesses human reader performance, often with and without AI assistance, particularly in areas like medical imaging. The IMMAGE system is a laboratory instrument for quantitative measurement, not a system intended to assist human "readers" in interpreting complex qualitative data.

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

The entire performance study described is essentially a "standalone" or "algorithm only" performance for the IMMAGE system reagents. The device itself performs quantitative measurements without human intervention in the measurement process once the sample is loaded. The tables show the performance of the IMMAGE system's measurement compared to the predicate device's measurement.

7. The Type of Ground Truth Used

The "ground truth" in these studies is the measurement obtained from the predicate device (Beckman Immunochemistry Systems Immunoglobulin Reagents). The studies are designed to show that the new IMMAGE system provides results that are substantially equivalent to a legally marketed equivalent device. This is a form of comparative ground truth against an established, accepted diagnostic method.

8. The Sample Size for the Training Set

The document does not mention a "training set." This terminology is more common for machine learning or AI-based devices. For a conventional in-vitro diagnostic (IVD) device like this, there isn't a "training set" in the same sense. The device is developed and validated through chemical and instrument design, followed by performance studies (method comparison, stability, imprecision) using a series of collected samples.

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

As there is no "training set" described in the context of this traditional IVD device, this question is not applicable. The underlying "ground truth" for the development of such reagents would be established through established analytical chemistry principles and assays used to characterize reference materials and calibrate the system.

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This product permits the quantitative in vitro diagnostic determination of Immunoglobulin G in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

quantex IgG: 8 x 6 mL anti-human IgG P/N 3000-22134; 2 x 100 mL Buffer P/N 3000-22130

Here's an analysis of the provided text regarding the quantex IgG device, focusing on the acceptance criteria and the supporting study:

The provided 510(k) summary is for an in vitro diagnostic device (IVD) and lacks the detailed performance data typically found in studies for diagnostic imaging or AI-driven devices. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC studies) are not applicable or cannot be extracted from this type of document.

Description of the Acceptance Criteria and Study for quantex IgG

This 510(k) summary describes the quantex IgG, an in vitro diagnostic test for the quantitative determination of Immunoglobulin G in serum and plasma. The device functions on the ILab Clinical Chemistry System via a turbidimetric immunoassay method. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, the IL Test™ IgG (K920006/B).

The acceptance criteria, in this context, are implicitly tied to demonstrating performance comparable to the predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (510(k) for an IVD), the "acceptance criteria" are not explicitly stated as distinct numerical thresholds for sensitivity, specificity, etc., as one might find for imaging devices. Instead, the acceptance criterion for substantial equivalence is demonstrated through a method comparison study showing a strong correlation with the predicate device.

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

• Sample Size for Test Set: Forty-seven (47) serum samples.
• Data Provenance: The document does not explicitly state the country of origin. It is a comparative performance study, implying the samples were processed on both the new device (quantex IgG on ILab) and the predicate device (IL Test™ IgG on Monarch Clinical Chemistry System). The study appears to be prospective in the sense that these specific samples were run to demonstrate equivalence, but the origin of the samples themselves (e.g., from a retrospective bank or prospectively collected for this study) is not specified.

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

N/A. For IVD devices like this, the "ground truth" is typically the measurement obtained from a reference method or a predicate device. There are no human experts involved in establishing a subjective ground truth measurement for IgG levels.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are relevant for subjective interpretations, often in imaging studies. For quantitative IVDs, the measurements are objective, and thus, no adjudication method is applicable.

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

N/A. MRMC studies are used for evaluating the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging. This document describes an IVD measuring an analyte and does not involve human readers interpreting results in a subjective manner.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

While the device's operation is "standalone" in the sense that it automates the measurement of IgG, the performance metrics reported here are specifically comparative to a predicate device. The output (an IgG concentration) is a direct, objective measurement from the algorithm/instrument, without a human interpretation step that would then be compared to an "AI-assisted" human interpretation.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by the predicate device, IL Test™ IgG, which itself would have been previously cleared by the FDA and accepted as a reliable method for measuring IgG levels. The study aims to show that the new device's measurements are essentially the same as those from the established predicate.

8. The Sample Size for the Training Set

N/A. This 510(k) summary describes a new diagnostic kit for an existing assay type (turbidimetric immunoassay for IgG). It does not involve a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of the instrument, if any, would refer to calibration procedures to ensure accurate measurements, but not a large dataset for algorithm learning.

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

N/A. As there is no "training set" for a machine learning algorithm, there is no ground truth established for it in this context. The instrument's calibration would rely on reference materials or calibrated controls, not a "ground truth" in the diagnostic performance evaluation context.

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