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The BioPlex™ 2200 Vasculitis kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), Proteinase 3 (PR3) and Glomerylar Basement Membrane (GBM) in human serum. In conjunction with clinical findings, the test system is used as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)associated vasculitides: Microscopic Polyangitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener's Granulomatosis and the autoimmune renal disorder, Goodpasture's syndrome.

The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System.

The BioPlex 2200 Vasculitis Calibrator Set is intended for the calibration of the BioPlex 2200 Vasculitis Reagent Pack.

The BioPlex 2200 Vasculitis Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Vasculitis Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Vasculitis Control Set has not been established with any other Vasculitis assays.

The BioPlex 2200 Vasculitis kit is a multiplex flow immunoassav intended for the semiquantitative detection of IgG autoantibodies to Myeloperoxidase (MPO), serine proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum.

The BioPlex 2200 Vasculitis kit is intended for use with the Bio-Rad BioPlex 2200 System.

Uses:

The test system is used to detect the presence of antibodies in serum samples, as an aid in the diagnosis of certain autoimmune vasculitides such as Microscopic Polyangilitis (MPA), Necrotising Glomerulonephritis, Churg-Strauss Syndrome, Wegener's Granulomatosis and autoimmune renal disorders, such as Goodpasture's syndrome, in conjunction with clinical findings and other laboratory tests.

The Vasculitis kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of beads are coated with antigens associated with vasculitis disease (MPO, PR3 and GBM). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, antibody, conjugated to phycoerythin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI),

Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information.

The instrument is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. The result for each of these antibodies is expressed as an antibody index (Al).

The provided text describes the BioPlex 2200 Vasculitis kit, calibrators, and controls. The document focuses on the performance summary, including expected values, reproducibility studies, and comparative testing against predicate devices and IFA methods.

However, the document does not explicitly state "acceptance criteria" for performance metrics in a clear, tabulated format. It presents performance results and compares them to predicate devices, implying that these results met internal criteria for substantial equivalence.

Therefore, the response below will synthesize the implied acceptance criteria from the reported performance, as direct acceptance criteria are not explicitly stated.

Acceptance Criteria and Study to Prove Device Meets Criteria: BioPlex 2200 Vasculitis Kit

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not stated, the table below infers the criteria based on the reported comparative performance in the 510(k) summary, specifically focusing on agreement with predicate EIA and IFA methods. The reported performance demonstrates substantial equivalence to predicate devices, which is the underlying requirement for 510(k) clearance.

2. Sample Size and Data Provenance for Test Set

• Normal Blood Donors: N=293, tested with BioPlex 2200 and corresponding commercial EIA methods.
• Unselected Patient Samples: N=300, previously tested with vasculitis tests, and tested with BioPlex 2200 and corresponding commercial EIA methods.
• Retrospective Anti-MPO Positive Samples: N=100, tested with BioPlex 2200, corresponding commercial EIA, and ANCA IFA.
• Retrospective Anti-PR3 Positive Samples: N=100, tested with BioPlex 2200, corresponding commercial EIA, and ANCA IFA.
• Retrospective Anti-GBM Positive Samples: N=27, tested with BioPlex 2200 and corresponding commercial EIA.
• Cross-reactivity study: 10 samples per cross-reactant (except 7 for anti-tTG), tested with BioPlex 2200 and corresponding commercial EIA.

Data Provenance: Not explicitly stated (e.g., country of origin, specific institutions). The samples are referred to as "normal blood donors," "unselected patient samples previously tested with vasculitis tests," and "retrospective samples positive for anti-MPO/PR3/GBM." The study was conducted at "two (2) US testing facilities and an internal site (Bio-Rad Laboratories)" for reproducibility, suggesting at least some US data. The studies are retrospective as they utilize "previously tested" and "retrospective" samples.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. Instead, it relies on comparative testing against "corresponding commercially available microplate EIA methods" and "ANCA IFA methods" which are presumably well-established and accepted diagnostic tests.

4. Adjudication Method for the Test Set

No adjudication method involving experts is mentioned. The ground truth for comparative effectiveness is established by the results of existing commercial assays (EIA and IFA). Discrepancies are reported (e.g., weak positive results, equivocal results) without specific details of an adjudication process beyond categorization.

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

No MRMC comparative effectiveness study was performed or described. This device is an in-vitro diagnostic kit for laboratory use, not typically subject to MRMC studies designed for imaging or complex diagnostic interpretations by multiple human readers. The study focuses on direct comparison of analyte detection performance between the new kit and predicate laboratory assays.

6. Standalone Performance

Yes, the standalone performance (algorithm only, without human-in-the-loop performance) is intrinsically what is presented. The device is a 'multiplex flow immunoassay' system designed to semi-quantitatively detect autoantibodies. Its performance metrics (e.g., agreement with predicate devices, reproducibility, cross-reactivity) are all measures of the device's standalone analytical capabilities.

7. Type of Ground Truth Used

The primary ground truth used is comparator assay results.

• Results from "corresponding commercially available microplate EIA methods" for MPO, PR3, and GBM.
• Results from "ANCA IFA method using ethanol-fixed slides" for anti-MPO (pANCA IFA) and anti-PR3 (cANCA IFA).

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The studies described are performance validation studies. In the context of IVD devices, a "training set" is not a standard concept as it might be for AI algorithms. The calibrator sets are used for instrument calibration, not for training a machine learning model.

9. How Ground Truth for the Training Set was Established

As no "training set" for an AI algorithm is mentioned, this question is not applicable. The device is an immunoassay kit, where calibration and control materials are used to ensure accurate measurement in routine use.

• Calibrators: "supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration." The ground truth for these calibrators would be established through careful characterization and quantification of the antibody concentrations by the manufacturer.
• Controls: Used "to monitor the overall performance." The positive and negative controls would have their status (positive/negative for each antibody) established by the manufacturer through rigorous testing.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to glomerular basement membrane(GBM) in human serum. The results of the anti-GBM assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GBM antibodies including Goodpastures Syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. For in vitro diagnostic use only.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GBM in human serum. This device is designed for use with the Hycor Hy•Tec Automated EIA instrument.

This document is a 510(k) clearance letter from the FDA for two devices: Autostat™ Anti-GBM ELISA and HY•TEC Anti-GMB ELISA. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given input.

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For the in-vitro measurement of specific IgG autoantibodies against the glomerular basement membrane (GBM) specifically the C-terminal end of type IV collagen, present in human serum. It is intended as an aid in the diagnosis of Goodpast's syndrome, in conjunction with other clinical findings.

BINDAZYME Anti-GBM EIA Diagnostic Test Kit

This document is a 510(k) clearance letter from the FDA for an in vitro diagnostic test kit, specifically the "Binding Site BINDAZYME® Anti-GBM Enzyme Immunoassay Diagnostic Test Kit."

It's important to understand that a 510(k) clearance for an in vitro diagnostic (IVD) device is fundamentally different from the regulatory process for AI-powered medical image analysis devices. The information requested in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the comprehensive clinical validation studies required for AI devices, especially those that provide diagnostic insights from medical images.

For an IVD like the one described in this document, the "performance" typically refers to analytical performance (sensitivity, specificity, precision, accuracy relative to a reference method) and clinical performance (how well the test results correlate with the presence or absence of the disease in a patient population, and its utility in diagnosis). The document provided is not a study report; it's an FDA clearance letter affirming substantial equivalence to a predicate device. Therefore, it does not contain the detailed study information you are asking for regarding acceptance criteria, sample sizes, expert involvement, or AI-specific validation methods.

However, I can infer and state what would typically be expected for such a device and what some of the closest information might be, based on the nature of a 510(k) submission for an IVD.

Absence of Specific Information:

The provided document (FDA 510(k) clearance letter) does not contain the detailed study information required to answer most of your questions about acceptance criteria and study design as it pertains to AI/ML devices. This document is a regulatory approval letter based on a separate submission, not the submission itself or a study report.

Inferences Based on IVD Nature and 510(k) Process (General Expectation, Not from Document):

For an in-vitro diagnostic (IVD) device, the "acceptance criteria" and "study" would typically refer to analytical and clinical performance studies, which are evaluated against a predicate device or accepted standards for diagnosing a specific condition.

Based on the provided document and general understanding of IVD 510(k) clearances, here's what can be stated or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not specified in the provided document. For an IVD like this, acceptance criteria would typically relate to analytical performance (e.g., sensitivity, specificity, precision, linearity, range) and clinical performance (e.g., agreement with a gold standard or predicate device in patient populations).
   • Reported Device Performance: Not explicitly detailed in the provided document. The FDA's letter states that "we have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device's performance, as demonstrated in its 510(k) submission, was deemed comparable to that of a predicate device already on the market. Specific metrics (e.g., sensitivity, specificity, accuracy values) are not present in this clearance letter.

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

   • Not specified in the provided document. For an IVD, the test set would typically involve patient samples (sera in this case) from individuals with and without the condition of interest. The size and characteristics of this sample set would have been part of the 510(k) submission.
   • Data Provenance: Not specified in the provided document. Typically, clinical studies for IVDs involve samples collected from various clinical sites. Whether these were prospective or retrospective samples is not mentioned.

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

   • Not applicable in the typical sense for this IVD. The "ground truth" for an IVD like the Anti-GBM EIA would be established through a combination of:
     • Clinical diagnosis: Based on patient symptoms, imaging, biopsy, and other laboratory tests.
     • Reference method(s): Comparison to other established laboratory tests or panels for GBM autoantibodies.
     • Pathological confirmation: In some cases, kidney biopsy findings would be definitive "ground truth."
   • Therefore, it's not about "experts establishing ground truth for a test set" in the context of image interpretation, but rather clinical and pathological confirmation of disease status.

4. Adjudication Method for the Test Set:

   • Not applicable as typically understood for AI evaluation. Adjudication (e.g., 2+1, 3+1) is common in reader studies for AI devices. For an IVD, the "ground truth" is established via clinical diagnosis and/or reference laboratory methods, not by multiple expert readers interpreting the test output for ground truth.

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

   • No, this is highly unlikely for an IVD kit. MRMC studies are primarily designed for evaluating the performance of imaging devices or AI algorithms that assist human readers in interpreting medical images. This device is a laboratory assay.

6. If a Standalone Performance was done:

   • Yes, in spirit, for an IVD. An IVD kit's performance is inherently "standalone" in that it provides a quantitative or qualitative result based directly on the patient sample. Its performance (e.g., sensitivity, specificity, positive predictive value, negative predictive value) would have been evaluated relative to the true disease status or a reference method. It operates without human interpretation of complex outputs in the way an AI image analysis algorithm does.

7. The Type of Ground Truth Used:

   • Likely a combination of clinical diagnosis, other established laboratory methods, and possibly pathology (e.g., kidney biopsy results) for the presence or absence of Goodpasture's syndrome. The device measures IgG autoantibodies against GBM, which is a specific marker for the disease. Ground truth would confirm the actual pathological or clinical state of the patient.

8. The Sample Size for the Training Set:

   • Not specified in the provided document. For an IVD, internal development and validation would involve numerous samples, but it's not referred to as a "training set" in the same way as for AI algorithms. It's more about assay optimization and internal validation samples.

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

   • Not specified in the provided document. For an IVD's internal development and optimization, ground truth would be established similarly to the test set: through well-characterized patient samples with known clinical and/or pathological diagnoses, or through spiked samples for analytical validation.

Summary:

The provided document is an FDA 510(k) clearance letter for an in vitro diagnostic test kit, not a detailed study report for an AI-powered device. Therefore, it does not contain the specific information about acceptance criteria, sample sizes, expert involvement, and AI-specific validation methods that your questions are structured around. The "study" for this device would have focused on analytical and clinical performance to demonstrate substantial equivalence to a predicate device, which is a different paradigm from AI device validation.

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A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called QUANTA Lite™ GBM ELISA. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the acceptance criteria or the details of a study proving the device meets those criteria, nor does it provide information about the development and testing of a new AI/ML device.

The letter is a regulatory approval, and while it references a 510(k) submission (K984336), the submission itself, which would contain the study details, is not provided in the input text. Therefore, I cannot extract the requested information.

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