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ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP® is a device for the in vitro semiquantitative measurement of IgA or IqG antibodies specific for gliadin in human serum. ImmunoCAP/UniCAP Gliadin IgAllgG ImmunoCAP is intended to be used with the instrument ImmunoCAP/UniCAP together with reagents as stated in the Directions for Use provided with ImmunoCAP/UniCAP Specific IgA and ImmunoCAP/UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease.

ImmunoCAP/UniCAP Specific IgA is an in vitro test system for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by ImmunoCAP/UniCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component of the ImmunoCAP/UniCAP Specific IgA system. ImmunoCAP/UniCAP Specific IgA assay is to be used with the instrument ImmunoCAP/UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

The Pharmacia ImmunoCAP Immunodiagnostic System is a fully integrated and automated system for immunodiagnostic testing. ImmunoCAP System is comprised currently of an instrument family, ImmunoCAP 100/250/1000 and individual assay products - Fluoro enzyme immunoassays reagents for the measurement of Immunoglobulin IgE, IgG, IgA, with ImmunoCAP Allergens/Antigens (solid phase components which contain the specific allergen/antigens to which antibodies are going to be measured), and Software Accessories.

ImmunoCAP instruments are designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests, samples and ImmunoCAP cariers are loaded into the instrument and the process, which takes about 2.5 hours, is started. A laboratory report is automatically printed when the process is ended.

ImmunoCAP instruments can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs. Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the instrument system software.

ImmunoCAP® System Information Data Manager (IDM) is intended to be used with a Windows-based PC operating up to five ImmunoCAP instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer.

ImmunoCAP Specific IgA is a fluoro enzyme immunoassay for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by ImmunoCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component (ImmunoCAP carrier). Specific IgA antibodies in the patient serum or plasma specimen react with the antigens of interest, in this submission, Gliadin, which are covalently coupled to the ImmunoCAP carrier solid phase.

After washing away non-specific IgA, enzyme labeled antibodies against IgA (ImmunoCAP/UniCAP Specific IgA Conjugate) is added to form a complex. After incubation, unbound enzyme-anti-IgA is washed away and the bound complex is incubated with a development agent. After stopping the reaction, the response of the eluate is measured. The response is directly proportional to the concentration of IgA in the serum sample.

The modification consists of a change from polyclonal Rabbit anti-human IgA antibodies to Mouse monoclonal anti-human IgA antibodies in the reagent ImmunoCAP/UniCAP Specific IgA Conjugate. No other reagents have been changed.

Here's a breakdown of the acceptance criteria and the study details for the ImmunoCAP® Specific IgA -/Gliadin/ Modified Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The core of this submission is a device modification, so the acceptance criteria are primarily focused on demonstrating substantial equivalence to the predicate device after the change. The main acceptance criteria appear to be a "good correlation" between the modified and predicate devices over the measuring range, and that any differences are "fully acceptable" for the intended use, without changes to the indications for use or clinical claims.

Note: The document does not explicitly state numerical thresholds for "good correlation," "small difference," "very good conformance," or "totally acceptable." These terms represent the qualitative acceptance criteria used in this summary.

Study Details

This submission describes a comparative study to demonstrate substantial equivalence following a device modification.

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

   • Sample Size: 182 samples
   • Data Provenance: Not explicitly stated, but the samples included "Gliadin specific IgA positive, negative and healthy individuals." Given that the manufacturer is in Sweden (Pharmacia Diagnostics AB, Uppsala, Sweden), it is plausible the samples are from this region, but this is not confirmed. The study appears to be retrospective as it's comparing a modified device to the previous version using existent samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study is a technical comparison of two versions of a diagnostic test (modified vs. predicate), not a diagnostic study requiring expert ground truth for clinical cases. The ground truth for the samples would be their known status (Gliadin specific IgA positive, negative, healthy) based on prior established diagnostic methods or clinical criteria.

3. Adjudication method for the test set: Not applicable, as this was a direct comparison of assay results rather than a clinical adjudication of patient cases.

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 not an AI/CAD device. It's a laboratory diagnostic assay for measuring specific IgA antibodies.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laboratory diagnostic assay. The "algorithm" here refers to the assay's chemical and enzymatic reactions, and the instrument's processing of results, which is inherently "standalone" in generating a quantitative measurement. Human intervention is required for sample collection, loading, and result interpretation in a clinical context.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the 182 samples was their status as "Gliadin specific IgA positive, negative and healthy individuals." This implies that their status was determined previously through established diagnostic methods for celiac disease or IgA levels, and/or clinical assessment. The document does not specify the exact nature of this "ground truth" (e.g., biopsy-confirmed celiac, other diagnostic tests).

7. The sample size for the training set: Not applicable. This is a device modification study for a laboratory assay. There's no "training set" in the context of machine learning or AI. The assay itself has established reagents and protocols validated through previous development and regulatory submissions (like the predicate device in K982533).

8. How the ground truth for the training set was established: Not applicable, as there is no training set in this context.

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UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. The system includes reagents (Conjugate, Calibrators, Curve Controls, Specific IgE ImmunoCAP and Allergen ImmunoCAP Carriers, Development Kit, Washing Solution) and ImmunoCAP instruments with built-in software. The assay principle involves allergen coupled to ImmunoCAP reacting with specific IgE in the patient sample, followed by incubation with enzyme labeled antibodies against IgE. After washing, the bound complex is incubated with a developing agent, and the fluorescence of the eluate is measured. The fluorescence response is transformed to concentrations using a calibration curve. The modification is a minor change to the calibrator system to extend the technical measuring range below 0.35 kUx/l by adding a 0 kU/l Calibrator and removing the 50 kU/l Calibrator, keeping 6 calibrators in total (0, 0.35, 0.7, 3.5, 17.5 and 100 kU/l).

Here's a breakdown of the acceptance criteria and the study details for the UniCAP Specific IgE device modification, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the sample size used for the test set.
• It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The study focuses on evaluating the modification of the calibrator system rather than clinical performance on patient samples in this specific filing.

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

This information is not provided in the document. The study described focuses on the technical performance of the device's calibration system, not on establishing a ground truth for clinical diagnosis of allergic disorders using expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a technical comparison of calibration curves and determination of Limit of Quantitation, not a study involving human adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The document describes a technical modification and verification of the device's measurement range and calibration.

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

Yes, in a sense, a standalone evaluation was performed. The study focused on the technical performance of the changed calibrator system as implemented in the device, without involving human interpretation or interaction during the measurement process. The device's instrument system processes all steps and prints results automatically.

7. The Type of Ground Truth Used

The "ground truth" for this study was primarily:

• Comparison against the previous/current calibration curves to assess conformity.
• Adherence to established laboratory protocols for determining Limits of Detection and Quantitation (NCCLS document EP-17A), which serves as a technical standard for assessing the accuracy of the assay's lower measurement range.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning or algorithm development. The study is about a modification to the calibrator system of an existing in vitro diagnostic device. The "calibration" of the device itself uses ImmunoCAP Specific IgE Calibrators 0-100 (which were modified in this update to 0, 0.35, 0.7, 3.5, 17.5 and 100 kU/l as the six points).

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

Given that this is a modification to an existing in vitro diagnostic assay and not an AI/machine learning device, the concept of a "training set ground truth" as it applies to AI is not directly relevant.

For the purpose of the device's operation, the "ground truth" for the calibrators is established by their known concentrations (e.g., 0, 0.35, 0.7, 3.5, 17.5, and 100 kU/l), which are presumably manufactured and certified to specific standards. These calibrators are used by the instrument's built-in software to create a calibration curve against which patient samples are measured.

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The Varelisa PR3 ANCA EIA kit is designed for the semi-quantitative and qualitative determination of proteinase 3 anti neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis.

Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma. The test kit contains microplate strips coated with human purified PR3 antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device, its intended use, and its comparison to a predicate device. However, it does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity thresholds) that the new device (Varelisa PR3 ANCA) needed to meet.

Instead, the study's goal was to demonstrate substantial equivalence to the predicate device (INOVA QUANTA Lite™ PR-3) and that it "performs as expected from the medical literature" and "according to state-of-the-art expectations." The evaluation was based on a comparative study.

Therefore, the table will reflect this comparative nature rather than explicit acceptance criteria.

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions a "data set including results obtained within a comparison study analyzing positive, equivocal and negative sera," and "results obtained for externally defined Calibrators and clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)." However, the exact number of samples for each category or overall is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "comparison study," which implies prospective collection for the purpose of the study. However, it's not definitively stated as retrospective or prospective, though the nature of comparing performance against an existing device suggests a concurrent, prospective analysis of samples.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned. The process of establishing "clinically defined sera" or the determination of "positive, equivocal and negative sera" is not detailed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

• MRMC Study: No. This study is an in-vitro diagnostic (IVD) assay comparison, not a multi-reader, multi-case study involving human readers interpreting images or data.

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

• Standalone Performance: Yes, in essence. The Varelisa PR3 ANCA is an automated in-vitro diagnostic (IVD) immunoassay kit. Its performance is evaluated directly based on its output (semi-quantitative and qualitative determination of PR3 ANCA) from human serum or plasma samples. There is no "human-in-the-loop" component in the performance of the device itself (though human laboratory personnel would run the test). The "algorithm" here is the biochemical reaction and detection system of the EIA.

7. The Type of Ground Truth Used:

The ground truth appears to be based on:

• Clinical Definition/Established Clinical States: "clinically defined sera." This likely refers to samples from patients with confirmed diagnoses of Wegener's granulomatosis (positive) and other relevant conditions or healthy controls (negative/equivocal).
• Predicate Device Results: The comparison study likely used the predicate device's results as a reference point for agreement for positive, equivocal, and negative sera.
• External Calibrators: Used to establish reference points within the assay itself.
• Medical Literature: Performance is deemed "as expected from the medical literature," implying existing knowledge about PR3 ANCA levels and their correlation with disease.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable/not mentioned. This is an immunoassay kit, not a machine learning algorithm that requires a "training set" in the traditional sense. The device's components (antigen, controls, calibrators) are designed and manufactured based on biochemical principles rather than trained on a dataset.

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

• Ground Truth for Training: Not applicable. As noted above, this is not a machine learning model where a training set with established ground truth is used to train an algorithm. The "ground" for the development of such an IVD kit would be the established biochemical understanding of antigen-antibody interactions and the clinical relevance of PR3 ANCA.

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The Varelisa Histone Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG and IgM antibodies to histone in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE) or druginduced lupus erythematosus (DIL).

Varelisa Histone Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. The wells of a microtiterplate are coated with human histone antigen. Antibodies specific for histones present in the patient sample bind to the antigen.

In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution.

The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.

This submission is for an in-vitro diagnostic device, not an AI/ML powered device. Hence the provided sections of the 510k summary do not include specific "acceptance criteria" based on performance metrics like sensitivity, specificity, or AUC, nor do they detail a study designed to "prove" the device meets such criteria in the way one might expect for an AI/ML algorithm.

Instead, the submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (INOVA QUANTA Lite™ Histone IgG). The "acceptance criteria" are implied by the demonstration of comparable performance and alignment with the predicate device regarding its intended use for aiding in the diagnosis of SLE or DIL.

Here's an interpretation based on the provided text, framed to address your requested points where applicable, and noting where information is not available due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in-vitro diagnostic (assay) device, the "acceptance criteria" are not explicitly stated as numerical performance targets (e.g., "sensitivity must be >90%"). Instead, they are interpreted as demonstrating comparable performance to the predicate device and expected results from medical literature. The "reported device performance" is qualitative and refers to the overall comparability.

• Results from a comparison study analyzing positive, equivocal, and negative sera.
• Results obtained for externally defined Calibrators.
• Results obtained for samples from apparently healthy subjects (normal population).
  The data show that the assay performs as expected from the medical literature. |
  | Accordance with Medical Literature: Performance should align with established medical understanding of histone antibodies in SLE/DIL diagnosis. | The data show that the assay performs as expected from the medical literature. |
  | Intended Use Fulfilled: Designed for semiquantitative and qualitative determination of IgG and IgM antibodies to histone. | The device is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. It detects Anti-Histone IgG and IgM antibodies. |
  | Methodological Comparability: Indirect noncompetitive enzyme immunoassay, similar sample dilutions, comparable antigens, and detection systems. | Both assays are indirect noncompetitive enzyme immunoassays for the semiquantitative determination of antibodies against Histone in serum. Both recommend the same sample dilutions and use comparable antigens and detection systems. (Note: Varelisa detects IgG and IgM, predicate detects only IgG). |

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

• Sample Size: Not explicitly stated. The text mentions "a comparison study analyzing positive, equivocal and negative sera" and "samples from apparently healthy subjects (normal population)," but no specific numbers are given for these cohorts.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).

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

• This information is not applicable and hence not provided for an in-vitro diagnostic assay comparison study. "Ground truth" for these types of tests typically refers to well-characterized patient samples with known clinical diagnoses or reference method results, rather than expert consensus on image interpretation.

4. Adjudication Method for the Test Set

• Not applicable and not provided for this type of device.

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

• Not applicable. This is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This is an assay kit; its performance is its standalone performance when used in a laboratory setting. There isn't an "algorithm" in the typical sense of AI/ML. The "device performance" described in point 1 serves as its standalone performance.

7. Type of Ground Truth Used

• The "ground truth" implicitly used for this type of comparison would be clinical diagnosis (e.g., patients diagnosed with SLE/DIL vs. healthy controls) and/or reference laboratory methods/externally defined calibrators for the detection of histone antibodies, against which the assay results are correlated. The text mentions "positive, equivocal and negative sera" and "samples from apparently healthy subjects (normal population)," implying clinically characterized samples.

8. Sample Size for the Training Set

• Not applicable. This is an immunoassay kit whose reagents and protocol are developed based on scientific principles of antigen-antibody binding, not through a "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

• Not applicable for the reasons mentioned in point 8.

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The Varelisa ssDNA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of anti-single stranded DNA (ssDNA) autoantibodies in serum or plasma. In conjunction with the Varelisa dsDNA Antibodies kit it assists in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases. The test is not definitive in isolation but has to be seen as one parameter in a multicriterion diagnostic process.

Varelisa ssDNA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ssDNA antibodies in human serum or plasma. Antibodies specific for ssDNA present in the patient sample bind to the antigen. The assay should be used in combination with the Varelisa dsDNA Antibodies.

The test kit contains microplate strips coated with synthetic ssDNA, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.

This document describes the Varelisa® ssDNA Antibodies, an indirect noncompetitive enzyme immunoassay for the semi-quantitative and qualitative determination of anti-single stranded DNA (ssDNA) autoantibodies in human serum or plasma. It is intended to assist in the diagnosis of systemic lupus erythematosus (SLE) and other rheumatic diseases, to be used in conjunction with a dsDNA antibodies kit.

1. Table of Acceptance Criteria and Reported Device Performance
The submission document states that "all available data support that the new device, PHARMACIA Varelisa ssDNA Antibodies Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ ssDNA Assay, and that the new device performs according to state-of-the-art expectations." However, specific numerical acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) and their corresponding reported device performance values are not explicitly provided in the given text.

The data provided primarily focuses on demonstrating "comparability" and "substantial equivalence" to the predicate device rather than defining and meeting specific quantitative acceptance criteria. The text mentions "results obtained within a comparison study analyzing positive, equivocal and negative sera" and "results obtained for samples from apparently healthy subjects (normal population)" to support comparability.

2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set during the comparison study. It mentions a "data set including: results obtained within a comparison study analyzing positive, equivocal and negative sera" and "results obtained for samples from apparently healthy subjects (normal population)."

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "comparison study" and involves "samples from apparently healthy subjects (normal population)," implying, but not confirming, a prospective collection for this specific study, or at least a retrospective analysis of collected samples for performance evaluation. It is not definitively stated if the data is retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish the ground truth for the test set.

4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size with AI vs Without AI Assistance
This device is an in-vitro diagnostic (IVD) immunoassay kit, not an AI-powered diagnostic system involving human readers interpreting images or data with or without AI assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This refers to a standalone performance evaluation of the device itself (the immunoassay kit) in determining ssDNA antibodies. The document implies that the "comparison study analyzing positive, equivocal and negative sera" and "results obtained for samples from apparently healthy subjects" were indeed a standalone evaluation of the device against established classifications of these samples. The general principle of an immunoassay kit is to provide a result directly, so the performance described aligns with a "standalone" evaluation of the assay.

7. The Type of Ground Truth Used
The document states that the comparison study involved "positive, equivocal and negative sera" and "samples from apparently healthy subjects (normal population)." This indicates that the ground truth was based on:

• Clinical Diagnosis/Classification: Samples were likely categorized as positive, equivocal, or negative for ssDNA antibodies, or as coming from "apparently healthy subjects," based on established clinical criteria, potentially including other diagnostic tests, clinical symptoms, and expert consensus.
• External Calibrators: "Results obtained for externally defined Calibrators" were also used, suggesting the use of reference materials with known concentrations.

8. The Sample Size for the Training Set
The document does not explicitly mention a training set in the context of an AI/machine learning model. This device is an immunoassay kit for antibody detection, not a machine learning algorithm that requires a distinct training set. The "data set" mentioned seems to be for performance evaluation/comparison rather than training.

9. How the Ground Truth for the Training Set Was Established
As a training set for an AI/machine learning model is not applicable in this context, the method for establishing its ground truth is not mentioned.

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The Varelisa ß2-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgA antibodies in serum or plasma.

The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

The Varelisa B2-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgA antibodies in serum or plasma.

The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

Here's an analysis of the provided text regarding the Varelisa® ß2 Glycoprotein I IgA Antibodies device, structured to address your specific questions about acceptance criteria and study details.

Please note: The provided text is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data with detailed acceptance criteria and standalone studies in the way a PMA might. As such, some of your requested information (e.g., specific quantitative acceptance criteria, standalone performance details, MRMC study results) is not explicitly present in the provided document. I will extract what is available and indicate when information is not provided.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary describes laboratory equivalence to a predicate device. It does not explicitly state quantitative acceptance criteria in a table format with specific thresholds. Instead, it relies on demonstrating comparable performance to the predicate device and expected behavior based on medical literature.

• Results for externally defined calibrators showed comparability.
• Results for samples from apparently healthy subjects (normal population) showed comparability. |
  | Suitability for Serum and Plasma Samples | - The device is outlined for use with serum and plasma, with corresponding performance data underlining its effectiveness with plasma as a sample. |
  | Performance in line with medical literature | - The assay performs as expected from the medical literature regarding the diagnosis of thrombotic disorders related to primary Antiphospholipid Syndrome or secondary to SLE/other autoimmune diseases. |
  | Decision Point Evaluation Method | - The Varelisa assay uses an OD cutoff for evaluation, and corresponding performance data show the comparability of results to the predicate device which uses a decision point method. |

2. Sample Sizes and Data Provenance for Test Set

• Sample Size for Test Set: Not explicitly stated as a single number. The document mentions a "data set including results obtained within a comparison study analyzing positive, equivocal and negative sera," and "results obtained for samples from apparently healthy subjects (normal population)." The specific number of samples in these comparison studies is not detailed.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be clinical laboratory evaluations. The document refers to "the medical literature" and "scientific knowledge" as a basis for the intended use and performance expectations, implying a broader, though unspecified, provenance for general knowledge. The manufacturer is based in Germany.
• Retrospective/Prospective: Not explicitly stated. Given it's a 510(k) comparison study, it's often retrospective use of banked samples, but this is not confirmed.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This device is an in-vitro diagnostic (IVD) immunoassay for autoantibodies. The "ground truth" for such devices typically relies on a combination of:

• Clinical diagnosis based on established medical criteria (e.g., for SLE, Antiphospholipid Syndrome).
• Results from a well-characterized predicate immunoassay or reference method.
• Clinical status of patients (e.g., "apparently healthy subjects").

The document does not mention the use of human experts (e.g., radiologists) establishing ground truth in the way it would for an imaging AI device. The ground truth seems to be implicitly derived from the clinical status of the patients and the results of the predicate device.

4. Adjudication Method for Test Set

No explicit adjudication method is described. The "ground truth" for an immunoassay comparison study is usually established by the clinical diagnosis of the patient and/or the result from the predicate device (or a gold standard if available), rather than a panel of expert reviewers adjudicating individual results.

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

No MRMC study was done. This type of study (evaluating human reader performance with and without AI assistance) is relevant for imaging AI devices that assist human interpretation. This device is an immunoassay kit for laboratory use and does not involve human "readers" in the diagnostic interpretation in the same way.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance was done in the sense that the device's performance was evaluated independently and then compared to a predicate device. The comparison studies evaluating "positive, equivocal and negative sera," "externally defined Calibrators," and "samples from apparently healthy subjects" represent evaluations of the device's standalone performance characteristics against expected outcomes or the predicate device. However, a specific "standalone" performance metric like sensitivity/specificity against a definitive gold standard not involving the predicate is not explicitly presented, as the emphasis is on substantial equivalence.

7. Type of Ground Truth Used

The ground truth appears to be a combination of:

• Clinical Status/Diagnosis: The intended use links the presence of antibodies to aiding in the diagnosis of thrombotic disorders related to Antiphospholipid Syndrome, SLE, or other autoimmune diseases. Samples were collected from "apparently healthy subjects" and presumably patients with known clinical conditions.
• Predicate Device Results: The entire study is a "comparison study analyzing positive, equivocal and negative sera" in relation to the predicate device, thereby using the predicate device's established performance as a de facto reference for "truth" in the context of substantial equivalence.

8. Sample Size for the Training Set

This document does not specify a separate "training set" or its size. This is typical for traditional IVDs like immunoassays, where extensive "training" in the machine learning sense is not performed. Assay development involves optimizing reagents, protocols, and cutoffs, which are different from training an ML algorithm on a dataset. The studies described are more akin to verification and validation.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/ML algorithm, this question is not applicable. The development and optimization of the immunoassay would rely on established laboratory practices, chemical principles, and clinical samples previously characterized by the predicate device or clinical diagnosis.

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The Varelisa ß2-Glycoprotein I IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgM antibodies in serum or plasma.

The presence of ß2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

The Varelisa B2-Glycoprotein I IgM Antibodies Assay is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in serum or plasma.

The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

Here's a summary 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

The provided text does not explicitly state numerical acceptance criteria (e.g., sensitivity, specificity thresholds) for the Varelisa® B2-Glycoprotein I IgM Antibodies device. Instead, the study aims to demonstrate substantial equivalence to a predicate device, the INOVA QUANTA Lite™ ß2 GPI IgM. The reported performance is based on qualitative comparisons and the conclusion of substantial equivalence.

• results obtained within a comparison study analyzing positive, equivocal and negative sera.
• results obtained for externally defined Calibrators.
• results obtained for samples from apparently healthy subjects (normal population)."** |
  | Effectiveness with serum samples | Implied to be effective as it's a common sample type for this assay type and compared to a predicate using serum. |
  | Effectiveness with plasma samples | "Corresponding performance data underline the effectiveness of the assay with plasma as sample." |
  | Performance as expected from medical literature | "The data show that the assay performs as expected from the medical literature." |
  | Comparability of evaluation methods (OD-cutoff vs. decision point) | "Corresponding performance data show the comparability of the results." |

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

• Sample Size: The exact numerical sample size for the test set (comparison study analyzing positive, equivocal, and negative sera; externally defined calibrators; normal population) is not specified in the provided text.
• Data Provenance: The text does not specify the country of origin of the data. It mentions "externally defined Calibrators" and "samples from apparently healthy subjects (normal population)". It is implied to be a retrospective study as it's a comparison study to a predicate.

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 text. The study focuses on demonstrating comparability between two assay kits, rather than establishing a gold standard diagnosis by human experts for the test set itself. The "ground truth" for the samples would have been their established status as positive, negative, or equivocal for the autoantibody.

4. Adjudication Method for the Test Set

This information is not provided in the text. Given it's a serological assay comparison, expert adjudication in the typical sense (e.g., for imaging interpretation) is unlikely to be the primary method for test set ground truth. The initial classification of samples (positive, negative, equivocal) would have been based on established laboratory methods or clinical diagnoses.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI devices where human interpretation is a key component. The Varelisa® B2-Glycoprotein I IgM Antibodies device is an in-vitro diagnostic (IVD) assay kit for laboratory use, not an AI-powered diagnostic tool for human reader improvement.

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

Yes, a standalone performance assessment was effectively done. The device itself is an in-vitro diagnostic assay that provides a result (semiquantitative or qualitative determination of antibodies) without direct human interpretation in the sense of an "algorithm only". The comparison study assesses the performance of this standalone assay against a predicate standalone assay. The results are based on the assay's output (e.g., optical density, antibody units), not on a human's interpretation of those results.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

The ground truth for the comparison study would likely have been established by:

• Clinical Diagnosis / Established Patient Status: Samples categorized as "positive, equivocal, and negative sera" would have their status determined by established clinical diagnoses of thrombotic disorders, SLE, or other autoimmune diseases, in conjunction with other laboratory findings.
• Reference Method Results: For the "externally defined Calibrators," their true value would be established by a reference method or traceable standard.
• Healthy Population Screening: "Samples from apparently healthy subjects (normal population)" would be considered negative by definition for the condition.

The text does not explicitly state "pathology" or "outcomes data" as the direct ground truth, but clinical diagnosis often relies on these.

8. The Sample Size for the Training Set

This information is not applicable / not provided for this type of medical device submission. The Varelisa® B2-Glycoprotein I IgM Antibodies is a chemical reagent-based assay kit, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The device's performance characteristics are established through analytical and clinical validation studies, not an algorithmic training process.

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

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

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The Varelisa B2-Glycoprotein I IgG Antibodies EIA kit is designed for the semiguantitative and qualitative determination of ß2-glycoprotein I IgG antibodies in serum or plasma.

The presence of ß2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

Varelisa B .- Glycoprotein I IgG Antibodies Assay is an indirect The noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ß2-glycoprotein I IgG antibodies in serum or plasma.

The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

The provided text describes the Varelisa® ß2 Glycoprotein I IgG Antibodies EIA kit and its comparison to a predicate device, but it lacks specific acceptance criteria as quantitative thresholds and a detailed study report that explicitly states how these criteria were met.

However, based on the provided text, I can infer the implied acceptance criteria, the general nature of the study conducted, and the reported device performance.

Here's an analysis of the information requested, based on the text:

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

The document does not explicitly state numerical acceptance criteria. Instead, it focuses on the comparability to a predicate device and performance as expected from medical literature.

• "Corresponding performance data show the comparability of the results" (referring to OD-cutoff vs. decision point method for evaluation).
• "All available data support that the new device...is substantially equivalent to the predicate device." |
  | Suitability for Intended Use (Serums & Plasma): | |
  | - Effective for use with serum samples. | - "The data show that the assay performs as expected from the medical literature." |
  | - Effective for use with plasma samples. | - "Corresponding performance data underline the effectiveness of the assay with plasma as sample."
• "The data show that the device is suitable for serum and plasma samples." |
  | Accuracy/Reliability (General): | |
  | - Performs as expected from medical literature. | - "The data show that the assay performs as expected from the medical literature."
• "The new device performs according to state-of-the-art expectations." |

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "a comparison study analyzing positive, equivocal and negative sera" and "results obtained for samples from apparently healthy subjects (normal population)," but no specific numbers of samples are provided for these test sets.
• Data Provenance: Not explicitly stated. The manufacturer is based in Germany (Pharmacia Deutschland GmbH), suggesting the study could have been conducted in Germany, but this is not confirmed. It is a retrospective or prospective study is not mentioned.

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

This information is not provided in the document. The method for establishing ground truth for the comparison study is not detailed.

4. Adjudication method for the test set

This information is not provided in the document.

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

An MRMC study is not applicable here. This device is an in vitro diagnostic (IVD) immunoassay kit for laboratory analysis, not an AI-assisted diagnostic tool that helps human readers (e.g., radiologists) interpret images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

This concept is not applicable as it's an IVD kit, not an algorithm that operates independently without human interaction (even lab technicians are "in the loop" for running the test and interpreting the results within the context of the patient's clinical picture). The device itself is the "standalone" diagnostic tool in a lab setting, providing a semi-quantitative or qualitative result.

7. The type of ground truth used

The type of ground truth is implied to be clinical diagnosis or established antibody status. The mention of "positive, equivocal and negative sera" suggests that the samples had a pre-determined status based on clinical findings, other laboratory tests, or established reference standards for ß2-glycoprotein I IgG antibodies. The intended use statement also highlights its role "in conjunction with clinical findings and other laboratory tests to aid in the diagnosis," which points towards clinical correlation as the ultimate ground truth.

8. The sample size for the training set

This information is not provided in the document. The document describes a comparison study, but not a distinct "training set" in the context of machine learning or algorithm development. The development of the immunoassay itself would involve internal validation and optimization, but the term "training set" is not used or detailed.

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

As no training set is explicitly mentioned, how its ground truth was established is not discussed in the document.

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The Varelisa B .- Glycoprotein I Antibodies Screen EIA kit is designed for the qualitative determination of B2-Glycoprotein I antibodies in human serum or plasma.

The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

The Varelisa ß2-Glycoprotein I Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against ß glycoprotein I in serum or plasma.

The test kit contains microplate strips coated with human purified ß2glycoprotein I. calibrator, negative control, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

The provided text describes a 510(k) summary for a medical device called Varelisa® ß2-Glycoprotein I Antibodies Screen. While it discusses the device's intended use and general performance, it does not explicitly state formal acceptance criteria in a quantifiable manner or detail a specific study designed to "prove" the device meets such criteria to the extent typically expected in a scientific study report.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (INOVA QUANTA Lite™ B2 GPI Screen) through comparative performance data. The "study" mentioned is a "comparison study analyzing positive, equivocal and negative sera," along with results for external calibrators and samples from healthy subjects.

Here's an attempt to extract the requested information based on the provided text, acknowledging limitations due to the nature of the 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) are not explicitly stated in the provided text, this table will represent the general comparative findings presented to establish substantial equivalence.

Note: The document states, "The data show that the assay performs as expected from the medical literature. Furthermore the performance data show that the device is suitable for serum and plasma samples." This implies that the 'acceptance criteria' were met by demonstrating similar performance to the legally marketed predicate and suitability for both serum and plasma.

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

• Test Set Sample Size: Not explicitly stated. The text mentions "a comparison study analyzing positive, equivocal and negative sera," "results obtained for externally defined Calibrators," and "results obtained for samples from apparently healthy subjects (normal population)." However, the specific number of samples in each category tested is not provided.
• Data Provenance: Not explicitly stated (e.g., specific country of origin or whether samples were prospective or retrospective). The manufacturer is based in Germany, so it's plausible the data collection predominantly occurred there or in Europe, but this is not confirmed. The study used "human serum or plasma."

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

This information is not provided in the document. For immunological assays like this, ground truth is typically established by clinical diagnosis, other laboratory tests, or established consensus among medical professionals. The document simply states the device aids in diagnosis "in conjunction with clinical findings and other laboratory tests."

4. Adjudication Method for the Test Set

This information is not provided. The text does not describe any expert adjudication process for the test results.

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

No. The device is an in-vitro diagnostic (IVD) immunoassay designed for qualitative determination of antibodies, not an imaging device typically assessed with MRMC studies or involving human readers interpreting outputs in such a way. The focus is on the device's accuracy in detecting specific antibodies rather than human interpretation of complex data. Therefore, there is no mention of human readers or an effect size for human improvement with AI assistance.

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

Yes. The data presented appears to refer to the standalone performance of the Varelisa® ß2-Glycoprotein I Antibodies Screen device itself, comparing its output to that of the predicate device and potentially to clinical expectations. As an automated immunoassay, its performance is inherently standalone in generating a result, which is then interpreted by a clinician in the context of other findings.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly detailed for the specific comparison study. However, for an immunoassay, the implicit ground truth would typically be established based on:

• Clinical diagnosis: Patients with primary Antiphospholipid Syndrome or SLE.
• Other laboratory tests: Results from established assays for B2-glycoprotein I antibodies or other relevant markers.
• Disease status: Classification of samples as "positive, equivocal and negative sera" implies a prior determination of their status, likely based on a combination of clinical criteria and/or predicate device results.

8. Sample Size for the Training Set

The document is a 510(k) summary for an immunoassay kit. Immunoassays are typically "trained" during their development and optimization phases, but the process is different from machine learning algorithms. The text does not provide any information about a "training set" or its size in the context of device development or any potential algorithm used.

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

As there is no mention of a training set in the provided text in the context of a machine learning algorithm, there is no information on how its ground truth would have been established. For traditional immunoassay development, the "ground truth" for calibrator and control materials is established through rigorous internal characterization and standardization, often against reference materials. However, details of this are not included here.

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The Varelisa Cardiolipin Antibodies Screen EIA kit is designed for the qualitative determination of antibodies against cardiolivin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).

The Varelisa Cardiolipin Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against cardiolipin in serum or plasma.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The provided 510(k) summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy percentages). Instead, the study focuses on demonstrating substantial equivalence to a predicate device and showing the assay "performs as expected from the medical literature."

The "reported device performance" is described in terms of its comparability to the original/predicate device.

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

The text does not provide specific sample sizes for the "test set." It mentions data from:

• "a comparison study analyzing positive, equivocal and negative sera."
• "externally defined Calibrators."
• "samples from apparently healthy subjects (normal population)."

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated. The manufacturer is based in Germany, so it's plausible the data originated from there or other European countries, but this is not confirmed.

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 information is not provided in the document. The text does not describe how ground truth was established for the comparison studies.

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

This information is not provided in the document.

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, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data. The study focuses on the analytical performance of the assay itself compared to a previous version.

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

Yes, in a sense, a "standalone" performance evaluation was done as this is an IVD device. The study evaluates the performance of the modified Varelisa® Cardiolipin Antibodies Screen assay as a standalone diagnostic tool, comparing it to its predicate version and its expected performance based on medical literature. Human intervention (other than laboratory procedures) in the interpretation of the assay result for diagnosis is inherent in the clinical use of such tests, but the submitted study evaluated the device's technical performance directly.

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

The document does not explicitly state the "ground truth" used for the comparison study. Given that it's a diagnostic test for antibodies, the ground truth would typically be established through:

• Clinical diagnosis of APS/SLE: For the "positive" and "negative" sera, this would likely involve a clinical diagnosis by physicians based on established criteria and other laboratory findings, or
• Reference laboratory methods: Comparison against a gold-standard or highly validated reference method for cardiolipin antibodies.
• Expert consensus: In some cases, expert panels might classify samples.

The text mentions "externally defined Calibrators," which would have their values established by a reference method.

8. The sample size for the training set

This information is not provided. Since this is an immunoassay and not a machine learning model, there isn't a "training set" in the typical AI/ML sense. The development of the assay, including optimizing the antigen supplier and blocking procedure, would have involved internal validation and optimization studies, but these are not described as a "training set" with specific sample sizes.

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

As there is no "training set" in the AI/ML context, this question is not applicable. For the development and optimization of the immunoassay, the "ground truth" would have come from established concentrations of analytes, known positive/negative samples, and comparison to existing validated methods during the assay development process. However, the details of these are not provided.

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