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An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

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This looks like a 510(k) clearance letter for an in-vitro diagnostic device, not an AI/ML medical device. As such, the typical acceptance criteria and study designs for AI/ML devices (like sample sizes for test sets, expert ground truth, MRMC studies) are not applicable or found in this type of document.

This document describes the regulatory clearance of the ImmuLisa™ dsDNA Antibody ELISA, an enzyme-linked immunosorbent assay, as an aid in diagnosing systemic lupus erythematosus (SLE).

Therefore, I cannot fulfill the request as the provided text relates to an IVD device and not an AI/ML device, and thus does not contain the information required to answer the prompt.

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The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

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The provided text is a letter from the FDA regarding the 510(k) premarket notification for the EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) device. While it states that the device is substantially equivalent to a predicate device and can be marketed, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance study details.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.

The document primarily focuses on regulatory approval and classification, not on the technical details of the validation study.

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This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results and clinical findings.

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This is a 510(k) premarket notification letter for the FARRZYME Human High Avidity Anti-dsDNA Enzyme Immunoassay Kit. The document does not contain the detailed acceptance criteria and study information you requested. It primarily focuses on the FDA's substantial equivalence determination.

Therefore, I cannot provide the requested information based on the provided text.

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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 Diamedix Is-anti-dsDNA an Enzyme Immunoassay (EIA) for the quantitative detection of IgG antibodies to double-stranded (ds) DNA in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is-anti-dsDNA Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of IgG antibodies to DNA in human serum.

Here's a summary of the acceptance criteria and the study details for the Is-anti-dsDNA Test System based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the Diamedix Is-anti-dsDNA Test System are implied by its performance in comparison to a commercially available anti-dsDNA ELISA test and its clinical sensitivity and specificity in characterized sera. The reported device performance is summarized below:

Note: For the Single Point Calibration method, the Relative Sensitivity was 99.1% (95.1-100.0% CI), Relative Specificity was 92.6% (88.8-95.4% CI), and Overall Agreement was 94.7% (91.7-96.6% CI). Precision for positive samples with Single Point Calibration also showed comparable CVs.

Study Details

1. Test Set Sample Size and Data Provenance:

   • Relative Sensitivity and Specificity: 413 samples. These samples comprised 200 sera from normal blood donors, 209 sera from clinical patients with either a diagnosis of SLE or another autoimmune disease, and 4 sera from patients whose status was unknown. The country of origin is not explicitly stated but implies a clinical laboratory setting. The data appears to be retrospective as it involves pre-existing samples.
   • Clinical Sensitivity and Specificity: 200 normal samples, 70 sera from patients with a diagnosis of SLE, and 138 sera from patients with suspected autoimmune disease. Data provenance is similar to the relative sensitivity/specificity study – clinical patient samples, likely retrospective.
   • Precision: Six sera and kit positive and negative controls were assayed in triplicate in two runs per day.
   • Linearity: The WHO Reference preparation, the kit 200 IU/ml Standard, and an in-house reference 200 IU/ml Standard were serially diluted and tested.

2. Number of Experts and Qualifications: Not specified in the provided text. The diagnosis of SLE and other autoimmune diseases for the clinical samples would have been established by medical professionals, likely rheumatologists or other specialists.

3. Adjudication Method: Not specified. The determination of patient diagnoses (SLE, autoimmune disease, normal) would have relied on established clinical diagnostic criteria, but the specific adjudication method for the samples used in this study is not detailed. Equivocal and "ONS" (Optimal Noise Suppression, likely meaning "Out of Specification" or similar, though not explicitly defined) samples were excluded from calculations in the relative performance study, and equivocal results were excluded from calculations in the clinical performance study.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. This device is an in-vitro diagnostic (ELISA test) for detecting antibodies, not an imaging or diagnostic AI device that typically involves human readers and AI assistance.

5. Standalone (Algorithm Only Without Human-in-the Loop) Performance: Yes, the performance metrics reported are for the standalone device (the Is-anti-dsDNA Test System) either used manually or on the MAGO Plus Automated EIA Processor. There is no human-in-the-loop component described for interpreting the assay results beyond reading the optical density and calculating antibody levels.

6. Type of Ground Truth Used:

   • For Relative Performance: The ground truth was established by comparison to another "commercially available anti-dsDNA ELISA test with traceability to the WHO Standard." This is a comparative ground truth based on an established reference assay.
   • For Clinical Performance: The ground truth was based on "diagnosis of SLE" and "diagnosis of suspected autoimmune disease" for patient groups, and "normal samples." This implies clinical diagnosis as the ground truth.
   • For Precision/Linearity: Ground truth is intrinsic to the assay (known concentrations, internal controls, reference standards).

7. Training Set Sample Size: Not applicable. This document describes a traditional ELISA diagnostic kit, not a machine learning or AI model that requires a training set in that sense. The "training" and optimization of the assay would have been part of the product development and validation process, but it's not described as a distinct training set for an algorithm.

8. How Ground Truth for Training Set was Established: Not applicable, as it's not an AI/ML device with a training set. The assay's performance characteristics (calibration, cut-offs) would have been established using well-defined standards and reference materials during its development.

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This assay is intended for the in-vitro measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings.

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The provided text is an FDA 510(k) clearance letter for the BINDAZYME Anti-dsDNA EIA device. This document confirms the device's substantial equivalence to a predicate device and its clearance for marketing. However, this type of regulatory document does not contain the detailed study information, acceptance criteria, or performance data that you have requested.

Specifically, the letter states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• The "Indications For Use" describes the device's intended purpose (in-vitro measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings).

To answer your questions about acceptance criteria, study design, sample sizes, ground truth establishment, or human reader performance, one would need access to the actual 510(k) submission document or the underlying scientific studies conducted by The Binding Site. This information is typically not included in the public-facing FDA clearance letter.

Therefore, I cannot provide the requested information based on the text provided.

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Liquichek Anti-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassay procedures for the detection of dsDNA autoantibodies.

Liquichek Anti-dsDNS Control is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

This looks like a 510(k) submission for an in vitro diagnostic device, specifically a quality control product. The information provided heavily focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device's own performance against acceptance criteria in the way a clinical diagnostic or AI-powered device would.

Therefore, many of the requested categories (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable in the context of this specific regulatory document. The "device performance" in this context refers to its characteristics compared to the predicate, not clinical accuracy or efficacy.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the typical sense of performance metrics for an AI or clinical diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to an existing legally marketed device (the predicate). The "performance" reported is a comparison of technological characteristics.

Note: While Form, Levels, Analytes, and Open Vial Claim show differences, the overall argument for substantial equivalence is made, likely by emphasizing the core "monitoring immunoassay procedures for dsDNA/nDNA autoantibodies" with a human serum matrix and similar storage conditions. The specific differences are acknowledged but not deemed to preclude equivalence for its intended use as a control.

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

• Sample Size: Not applicable. This is not a study testing the diagnostic accuracy or performance on patient samples. It's a characterization of a quality control product.
• Data Provenance: Not applicable.

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

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

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This type of study is for evaluating the impact of a diagnostic aid (like AI) on human reader performance, which is not relevant for a quality control product.
• Effect Size: Not applicable.

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

• Standalone Study: No. This device is a quality control material, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of diagnostic accuracy. For a quality control material, the "ground truth" would be the assayed values of the analytes within the control, which are then used to monitor other assays. However, this document describes it as an "unassayed quality control," meaning its exact values are not provided by the manufacturer but determined by the user's specific assay. The primary "ground truth" for this 510(k) is the established characteristics of the predicate device.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. There is no training set for a quality control product.

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

• Ground Truth Establishment: Not applicable.

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The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.

The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA.

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This is an FDA Premarket Notification (510(k)) K983422 for the Zeus Scientific, Inc. Aptus (Automated) Application for the dsDNA Test System.

Based on the provided text, it is not possible to fully answer all aspects of your request as the document is a regulatory approval letter and does not contain detailed study information. However, I can extract what is available and indicate what information is missing.

Here's a breakdown of the available information and missing details:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The letter is an FDA approval for marketing based on substantial equivalence, but it does not detail specific acceptance criteria for a study or numerical performance results.

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

This information is not present in the provided document.

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

This information is not present in the provided document.

4. Adjudication method for the test set

This information is not present in the provided 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

This information is not present in the provided document. The device is for "manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA," suggesting an in-vitro diagnostic, not an imaging device typically associated with MRMC studies or human reader improvement with AI assistance in the way you've described.

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

The device is named "Aptus (Automated) Application for the dsDNA ELISA Test System" and states it is intended for "manual or automated analysis." This implies that a standalone, automated performance was considered or is an intended use, but the document does not provide details of such a study.

7. The type of ground truth used

This information is not explicitly stated in the provided document. For a dsDNA ELISA test, the ground truth would typically be established by a reference method or clinical diagnosis of autoimmune disease (e.g., systemic lupus erythematosus), but the document does not specify.

8. The sample size for the training set

This information is not present in the provided document.

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

This information is not present in the provided document.

Summary of what is known from the document:

• Device Name: Aptus (Automated) Application for the dsDNA ELISA Test System
• Intended Use: The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to dsDNA. It is used in the diagnostic work-up of patients with suspected connective tissue diseases, as the presence of autoantibodies to nuclear constituents has proven useful in diagnosing various connective tissue diseases.
• Regulatory Status: Substantially equivalent to legally marketed predicate devices, classified as Class II, Product Code LRM.
• Type of Device: In-vitro diagnostic device.

To obtain the detailed study information you're asking for, you would typically need to review the 510(k) submission document itself, which would contain the preclinical and clinical study reports. The provided text is only the FDA's decision letter.

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