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Yumizen C1200 Immunoglobulin A reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin A (IgA) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other findings,

Yumizen C1200 Immunoglobulin G reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin G (IgG) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other findings.

Yumizen C1200 Immunoglobulin M reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin M (IgM) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

This test should be used in conjunction with other laboratory and clinical findings.

This submission consists in the Yumizen C1200 Immunoglobulin A (1300023881), Yumizen C1200 Immunoglobulin G (1300023883) and Yumizen C1200 Immunoglobulin M (1300023884) reagent for serum and plasma testing for Yumizen C1200 reagent.

The Yumizen C1200 Level 1 Protein Control (1300023944) and Yumizen C1200 Level 2 Protein Control (1300023945) for use on Yumizen C1200 Analyzer and the Yumizen C1200 Protein Cal (1300023893) for use on Yumizen C1200 Analyzer are sold separately.

This document describes the analytical performance characteristics of the Yumizen C1200 Immunoglobulin A, G, and M reagents, intended for quantitative in vitro diagnostic determination of immunoglobulins in serum and lithium heparin plasma. The study aims to demonstrate that the device meets acceptance criteria for various analytical parameters, ensuring its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Measuring Range (Linearity):
  • IgA, IgG, IgM: Samples were "spiked" to create different concentrations, then serially diluted. The exact number of initial samples for spiking is not specified, but dilutions were "assayed in quadruplicate within a single run."
• Precision (Total Precision: analyzer variability - 20x2x2 study):
  • IgA, IgG, IgM: 5 human sera samples and 2 levels of Yumizen C1200 Protein Control. Tested with "two replicates per run, two runs per day for 20 days on each of three analyzers" (n=240 per sample).
• Precision (Lot to Lot variability study: 3x5x2x3):
  • IgA, IgG, IgM: 5 human sera samples and 2 levels of Yumizen C1200 Protein Control. Tested in "triplicates per run, two runs per day for five days on each of three lots" (n=90 per sample).
• Interferences: The exact sample size is not stated, but the study implies testing samples with varying concentrations of interfering substances to determine acceptable bias.
• Matrix Comparison:
  • IgA: 62 paired samples (serum and heparinized plasma) from single donors.
  • IgG: 45 paired samples (serum and heparinized plasma) from single donors. Of these, 43 were used for correlation analysis.
  • IgM: 43 paired samples (serum and heparinized plasma) from single donors.
• Method Comparison:
  • IgA: 190 "native samples" from human serum.
  • IgG: 214 "native samples" from human serum.
  • IgM: 153 "native samples" from human serum.

Data Provenance: The human serum samples used for precision, matrix comparison, and method comparison studies were "anonymous remnants of human serum specimens collected from blood bank." "Spiked" samples were used for linearity studies, and "normal samples" from a blood bank were used for reference range verification. The document does not explicitly state the country of origin, but the manufacturer is based in France. The studies appear to be prospective analytical performance evaluations.

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

No external experts are mentioned for establishing ground truth in these analytical performance studies. The studies rely on established CLSI guidelines for evaluation and comparison with a legally marketed predicate device. The ground truth for quantitative measurements is the direct measurement by the devices themselves and comparison against predicate devices or known spiked concentrations.

4. Adjudication Method for the Test Set

Not applicable. These are analytical performance studies for an in vitro diagnostic device, not studies involving human interpretation or adjudication.

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

No. This document describes the analytical performance of an in vitro diagnostic reagent and analyzer system, not a device requiring human interpretation for diagnostic purposes where MRMC studies would typically be conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this can be considered a standalone performance study. The Yumizen C1200 system (reagents and analyzer) performs the quantitative determination of immunoglobulins. The studies evaluate the analytical capabilities of the system itself, such as accuracy (via method comparison, linearity), precision, interference, and stability, without direct human intervention in the result generation or diagnostic interpretation loop. The intent is to demonstrate the device's ability to accurately measure predefined analytes.

7. Type of Ground Truth Used

The ground truth for these analytical performance studies is established through:

• Known concentrations: For linearity studies, spiked samples with known concentrations were used.
• Predicate device measurements: For method comparison, results from the candidate device were compared against measurements obtained from legally marketed predicate devices (Beckman Coulter's Olympus IgA, IgG, IgM reagents on AU analyzers).
• CLSI guidelines and established methodologies: The studies adhere to CLSI guidelines (e.g., EP05-A3 for precision, EP17-A2 for detection capability, EP06-A for linearity, EP25-A for stability, C28-A3 for reference intervals, EP-9A3 for method comparison) which define accepted methods for evaluating analytical performance and establishing performance characteristics.
• Literature-established reference ranges: For reference range verification, the device's measurements on "normal" samples were compared against ranges cited in scientific literature (e.g., Dati et al., 1996).

8. Sample Size for the Training Set

The document does not explicitly delineate a "training set" in the context of machine learning or AI models. This device is an in vitro diagnostic reagent and analyzer system, not an AI/ML-based diagnostic algorithm that typically undergoes a distinct training phase with a dedicated dataset. The performance studies described here are for analytical validation rather than algorithm training.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this in vitro diagnostic device. The analytical evaluations described involve testing the reagent and instrument system, not training a learning algorithm.

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IGALC reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.

The IMMAGE® Low Concentration Immunoglobulin A (IGALC) Reagent and Cerebrospinal Fluid Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of immunoglobulin A in serum and cerebrospinal fluid.

The provided text describes a 510(k) submission for a medical device, which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable metrics. The submission states that "Performance data from validation testing supports equivalency," but it does not provide the actual data, acceptance criteria, or a description of the study design in the provided text.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

• Cannot be determined. The document states "Performance data from validation testing supports equivalency" but does not provide specific acceptance criteria (e.g., accuracy, precision targets) or the actual reported performance values for the device. The modification was "to reflect performance of the current reagent production processes," implying the performance itself was not significantly changed from the predicate.

2. Sample size used for the test set and the data provenance:

• Cannot be determined. The document does not provide any information about the sample size of the test set or the origin of the data.

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

• Not applicable/Cannot be determined. This device is a diagnostic reagent for quantitative determination of Immunoglobulin A. The "ground truth" would typically be established by a reference method or known concentrations, not by expert interpretation in the way, for example, a radiology image would be. No information is provided about how the ground truth for any validation was established.

4. Adjudication method for the test set:

• Not applicable/Cannot be determined. Similar to point 3, adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple experts might disagree. This is not relevant to a quantitative chemical assay.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a reagent for an automated immunoassay system, not an AI-assisted diagnostic tool that human readers would interact with.

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

• Not applicable. This device is a reagent kit used on an automated instrument. Its performance is inherently standalone in the sense that the instrument processes the sample without human interpretation of raw data, but it's not an "algorithm only" in the modern AI sense. The performance of the "device" (reagent and system together) is what's being evaluated.

7. The type of ground truth used:

• Cannot be determined. While it would logically be against a reference method or known concentration standards for a quantitative assay, the document does not explicitly state the type of ground truth used for validation.

8. The sample size for the training set:

• Not applicable/Cannot be determined. This device is a chemical reagent, not a machine learning model, so there isn't a "training set" in the computational sense. The "training" would refer to the development and optimization of the reagent formulation and assay parameters, but sample sizes for this are not provided.

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

• Not applicable/Cannot be determined. As above, there is no "training set."

Summary of what can be extracted:

• Device Name: IMMAGE® Systems Low Concentration Immunoglobulin A (IGALC) Reagent
• Intended Use: Quantitative determination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry, when used with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator.
• Modification: The serum methods comparison data has been modified to reflect performance of the current reagent production processes. All other performance parameters remain unchanged.
• Equivalency Claim: Performance data from validation testing supports equivalency to the predicate device (IMMAGE Systems Low Concentration Immunoglobulin A Reagent, FDA 510(k) Number K993549).

The provided text is a 510(k) summary, which is typically a high-level overview. A full 510(k) submission would contain the detailed studies and data to support these claims, but that detailed information is not present in the given excerpt.

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Immunoturbidimetric assay for the quantitative in vitro determination of IgA 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 IgA Gen.2 is an immunoturbidimetric assay. Anti-IgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for the Tina-quant IgA Gen.2, focusing on demonstrating substantial equivalence to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance: While there's a table comparing the new device to the predicate in terms of intended use, method, sample type, measuring range, and expected values, these are not acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or a direct report of the new device's performance against such criteria.
• Sample size and data provenance for a test set.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or related effect size.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily describes the device, its intended use, and argues for its substantial equivalence to a previously cleared device (Tina-quant IgA, K955907) based on similarities in methodology, intended use, and slight modifications to the measuring range and expected values. It's a regulatory submission for clearance, not a detailed performance study report.

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In vitro diagnostic reagents for the quantitative determination of IgA in human cerebrospinal fluid (CSF) and in paired CSF and serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgA aids in the evaluation of the patient's immune system.

Polystyrene latex particles coated with specific antibodies to human IgA are agglutinated when mixed with samples containing IgA. The intensity of scattered light in the BN™ Systems depends on the IgA concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.

Here's a breakdown of the acceptance criteria and study information for the N Latex IgA device, based on the provided text:

Acceptance Criteria and Device Performance

• CSF (n=50): Slope = 1.008, Intercept = -0.324, Correlation Coefficient = 0.991
• Serum (n=50): Slope = 1.123, Intercept = -0.067, Correlation Coefficient = 0.992
• Serum/CSF Ratio (n=50): Slope = 0.910, Intercept = -0.146, Correlation Coefficient = 0.988 |

Note: The document explicitly states the N Latex IgA is "substantially equivalent in intended use and results obtained to the IMMAGE® IGALC assay." The provided "Device Performance Characteristics" table directly reports the correlation metrics (slope, intercept, and correlation coefficient) as evidence of this equivalence, implying these values met the internal acceptance criteria for demonstrating substantial equivalence. Excellent correlation coefficients (all above 0.98) and slopes close to 1.0, with small intercepts, typically indicate strong agreement between two measurement methods.

Study Details:

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

   • Sample Size:
     • CSF: 50 samples
     • Serum: 50 samples
     • Serum/CSF Ratio: 50 samples (presumably derived from the same CSF and Serum samples)
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

   • The concept of "ground truth" established by experts is not applicable here as this is a quantitative diagnostic device comparing its performance to a predicate device.
   • The "ground truth" in this context is the quantitative result obtained from the legally marketed predicate device (Beckman Coulter IMMAGE® Immunochemistry System IGALC assay).

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

   • Not applicable. This is a comparison between a new device and a predicate device, not an interpretation task requiring adjudication of expert opinions.

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:

   • No. This is a study comparing a new diagnostic device's quantitative measurements to an existing predicate device, not an MRMC study involving human readers or AI assistance.

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

   • Yes, this was a standalone performance evaluation. The N Latex IgA device (an in vitro diagnostic reagent system) was tested to determine its quantitative output for IgA, and these outputs were then correlated with results from a predicate device. There is no human-in-the-loop component described for the measurement process itself, although human operators would run the tests.

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

   • The "ground truth" for this study was the quantitative IgA measurements obtained from the legally marketed predicate device, the Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) assay (K993549).

7. The sample size for the training set:

   • Not applicable. This document describes a performance evaluation for regulatory submission, not the development or training of an algorithm in the machine learning sense. The device is a "particle-enhanced immunonephelometry system," which relies on biochemical reactions and optical detection, not a machine learning model that requires a training set.

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

   • Not applicable, as there is no "training set" in the context of this type of diagnostic device.

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

The Wako IgA II-HA test is a highly specific reagent based on turbidimetric immunoassay. When a sample is mixed with the Buffer solution and Anti-IgA, IgA in the sample combines specifically with anti-human IgA antibody in the Anti-IgA to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgA in the sample.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the device study:

Device: Wako IgA II-HA test (for quantitative determination of immunoglobulin A in serum)

Acceptance Criteria and Device Performance

The provided documentation does not explicitly state pre-defined "acceptance criteria" in the format of a threshold that the device needed to meet. Instead, the safety and effectiveness are established through substantial equivalency to a predicate device (Wako IgA HA-Direct product). The performance metrics reported are primarily comparative.

Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not presented, the table below reflects how the device performance was compared to its predicate to establish substantial equivalence.

Study Details

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

   • The document does not specify the sample size for the comparison study.
   • The country of origin for the data is not specified.
   • The study type (retrospective or prospective) is not specified.

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

   • This information is not provided. The comparison is against a predicate device, which implies the predicate's measurements serve as a reference, but it doesn't detail how the "ground truth" for the predicate itself was established in this context.

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

   • This type of adjudication method is not applicable as the study described is a comparison of two quantitative analytical devices, not an interpretive task often subject to expert adjudication.

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:

   • No, an MRMC comparative effectiveness study was not conducted. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

   • Yes, the performance evaluated is that of the device algorithm (turbidimetric immunoassay) in a standalone manner, as it quantitatively determines IgA in serum. Human intervention is involved in operating the device and collecting samples, but the core measurement and comparison are algorithm-driven.

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

   • The "ground truth" in this context is implicitly the measurements obtained from the predicate device, Wako IgA HA-Direct product. The study demonstrates the correlation and regression of the new device's measurements against those of the legally marketed predicate. This is a common approach for establishing substantial equivalence for IVDs.

7. The sample size for the training set:

   • The concept of a "training set" is not applicable here as this is a traditional in-vitro diagnostic assay validation, not a machine learning model.

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

   • Not applicable, as there is no training set mentioned in the context of a machine learning model.

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

Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A 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 A in the sample.

This document describes the Abbott Laboratories Immunoglobulin A (IgA) assay, an in vitro diagnostic device. The study presented focuses on demonstrating substantial equivalence to a predicate device rather than setting new acceptance criteria based on novel clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the exact sample size used for the comparative performance studies (method comparison and precision studies). It mentions "two levels of control material" for precision studies, but not the number of replicates or runs for each. The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective), but it is implied to be from internal studies conducted by Abbott Laboratories for the purpose of this 510(k) submission.

3. Number of Experts and Qualifications

Not applicable. This is an in vitro diagnostic assay, and the ground truth is established through laboratory methods and comparison to a legally marketed predicate device, not through expert human review of images or clinical cases.

4. Adjudication Method

Not applicable. This is an in vitro diagnostic assay.

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

Not applicable. This is an in vitro diagnostic assay, not a medical imaging or diagnostic aid device that involves human readers.

6. Standalone Performance

Yes, a standalone performance was done. The IgA assay's performance characteristics (correlation, precision, assay range, sensitivity) were evaluated independently on the AEROSET™ System against the K-ASSAY® Immunoglobulin A assay run on the Hitachi® 717 Analyzer. This is a comparison of two analytical methods, effectively demonstrating the standalone performance of the new device relative to the predicate.

7. Type of Ground Truth Used

The ground truth for the comparative performance study was established by the K-ASSAY® Immunoglobulin A assay on the Hitachi® 717 Analyzer, which is the legally marketed predicate device. This is a form of comparative analytical performance against an established method.

8. Sample Size for the Training Set

Not applicable. This is a chemical assay, and the "training set" concept (as it pertains to machine learning algorithms) does not apply here. The device's performance is based on its inherent chemical and optical properties and established analytical protocols.

9. How Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8. The device operates based on established laboratory principles, not a learned algorithm from a training set. The performance is validated through comparison to a well-established and legally marketed predicate device.

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

quantex IgA: 8 x 6 mL anti-human IgA P/N 3000-22133; 2 x 100 mL Buffer P/N 3000-22130

This document is a 510(k) summary for a medical device called "quantex IgA" and does not contain the detailed information necessary to complete the requested table and study description. It is focused on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data against pre-defined acceptance criteria.

However, based on the provided text, I can extract some limited information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: 45 serum samples
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). It mentions "serum samples," implying human origin.

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

• Not applicable. This device measures a quantitative biomarker (IgA levels), and the "ground truth" for method comparison is typically considered the result from an established, predicate method, not a subjective expert assessment.

4. Adjudication method for the test set

• Not applicable. As this is a quantitative measurement compared to a predicate device, adjudication by experts for discrepancies is not relevant.

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

• No. This is a clinical chemistry assay for measuring IgA levels, not an imaging or diagnostic AI device that involves human reader interpretation.

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

• Yes, implicitly. The device (quantex IgA on an ILab Clinical Chemistry System) independently measures IgA levels. The performance evaluated against the predicate device is a standalone comparison.

7. The type of ground truth used

• The "ground truth" for the comparative performance study was the measurements obtained from the predicate device (IL Test™ IgA on a Monarch Clinical Chemistry System).

8. The sample size for the training set

• Not applicable. This document describes a traditional in vitro diagnostic device, not a machine learning or AI-based device that typically has a "training set."

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

• Not applicable.

Summary of Limitations of the Provided Text:

The provided 510(k) summary is designed to establish substantial equivalence, not to detail internal validation studies with explicit acceptance criteria for performance metrics like precision, linearity, limits of detection, etc., or to provide a "study that proves the device meets the acceptance criteria" in that sense. It focuses on the correlation with a legally marketed predicate device as the primary evidence of performance.

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