(173 days)
The Wieslab™ Cap PR3-ANCA is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to proteinase 3 (PR3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. The assay is intended for use in patients with signs and symptoms consistent with WG. It is not intended for screening a healthy population. The analysis should be performed by trained laboratory professionals.
The Capture-PR3-ANCA test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to proteinase 3 (PR3) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. The assay is intended for use in patients with signs and symptoms consistent with WG. It is not intended for screening a healthy population. The analysis should be performed by trained laboratory professionals.
The wells of the microtiter strips are coated with monoclonal antibody to proteinase 3 and subsequently proteinase 3. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
Here's an analysis of the provided text to fulfill your request:
Acceptance Criteria and Study Details for Capture PR-3 ANCA Test Kit
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state pre-defined acceptance criteria for the clinical sensitivity and specificity. However, based on the presented data and the regulatory context of a 510(k) submission, the performance of the predicate device serves as the implicit benchmark for substantial equivalence. The reported performance for the new device is as follows:
| Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Clinical Sensitivity for WG (Wegener's granulomatosis) | High sensitivity for WG (consistent with predicate) | 96.0% (48/50) with 95% CI (86.3-99.5%) |
| Clinical Sensitivity for MP (Microscopic polyangiitis) | (Not explicitly defined, but shown for comparison) | 46.9% (15/32) with 95% CI (29.1-65.3%) |
| Clinical Specificity for Normal Blood Donors | High specificity (consistent with predicate) | 100% (120/120) with 95% CI (97.0-100%) |
| Clinical Specificity for SLE (Systemic Lupus Erythematosus) | High specificity (consistent with predicate) | 100% (44/44) with 95% CI (92.0-100%) |
| Clinical Specificity for RA (Rheumatoid Arthritis) | High specificity (consistent with predicate) | 100% (16/16) with 95% CI (79.4-100%) |
| Clinical Specificity for GBM (Glomerular Basement Membrane) | High specificity (consistent with predicate) | 89.7% (26/29) with 95% CI (72.7-97.8%) |
| Relative Sensitivity (compared to alternative ELISA) | High (consistent with predicate) | 100% (40/40) with 95% CI (91.2-100%) |
| Relative Specificity (compared to alternative ELISA) | High (consistent with predicate) | 98.5% (134/136) with 95% CI (94.8-99.8%) |
| Relative Accuracy (compared to alternative ELISA) | High (consistent with predicate) | 98.9% (174/176) with 95% CI (96.0-99.9%) |
| Batch to Batch CV% (PK sample) | Low variability | 13% |
| Batch to Batch CV% (K1 sample) | Low variability | 7% |
| Batch to Batch CV% (K3 sample) | Low variability | 11% |
| Inter-Assay CV% (PK sample) | Low variability | 6% |
| Inter-Assay CV% (K1 sample) | Low variability | 6% |
| Inter-Assay CV% (K2 sample) | Low variability | 7% |
| Inter-Assay CV% (K3 sample) | Low variability | 7% |
| Linearity (r value) | Close to 1 | 0.95, 0.94, 0.98 for three sera |
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Sensitivity and Specificity Study (Table 1):
- Sample Size: 295 frozen sera (120 blood donors, 50 WG, 34 MP, 45 SLE, 17 RA, 29 GBM).
- Data Provenance: Retrospective sera. Country of origin is not explicitly stated.
- Comparison to IIF-ANCA (Table 2):
- Sample Size: 78 frozen retrospective sera from systemic vasculitis.
- Data Provenance: Retrospective sera. Country of origin is not explicitly stated.
- Comparison to Alternative ELISA (Table 3):
- Sample Size: 180 frozen retrospective sera.
- Data Provenance: Retrospective sera. Country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions "clinical characterisation" for the samples in Table 1 and "IIF-ANCA" and an "alternative ELISA" as comparators in Tables 2 and 3, respectively. This suggests that the ground truth was based on established clinical diagnoses and/or results from other diagnostic methods, though the specific process and expert involvement are not detailed.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The ground truth appears to be based on pre-existing clinical characterization or results from predicate/alternative assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This document describes an Enzyme-Linked Immunosorbent Assay (ELISA) kit, which is a laboratory diagnostic device, not an AI-powered image analysis or diagnostic tool involving human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The "Capture PR-3 ANCA Test Kit" is an in-vitro diagnostic ELISA kit. Its performance is inherently standalone in the sense that the assay itself generates a result (optical density, converted to arbitrary units) without a human "in-the-loop" during the measurement process. The interpretation of these results for diagnosis is then done by trained laboratory professionals. So, yes, it functions as a standalone diagnostic assay.
7. The Type of Ground Truth Used:
- Clinical Sensitivity and Specificity Study (Table 1): The ground truth was based on clinical characterization of the patients' conditions (e.g., diagnosed with Wegener's granulomatosis, systemic lupus erythematosus, etc., or healthy blood donors).
- Comparison to IIF-ANCA (Table 2): The ground truth was based on the results of IIF-ANCA (Indirect Immunofluorescence - Anti-Neutrophil Cytoplasmic Antibodies), a well-established method for detecting ANCA.
- Comparison to Alternative ELISA (Table 3): The ground truth was based on the results of an alternative PR3-ANCA ELISA kit (presumed to be the predicate device or a similar commercially available assay).
8. The Sample Size for the Training Set:
The document describes performance studies (validation) with test sets. There is no mention of a separate "training set" for an algorithm, as this device is a biochemical assay kit rather than a machine learning model. The assay's parameters (e.g., calibrator values) would have been established during its development and manufacturing, but this is not typically referred to as a "training set" in the context of IVD kits.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the context of an algorithm or machine learning model for this ELISA kit, this question is not applicable. The assay's inherent design and calibration are based on biochemical principles and established standards, rather than data-driven ground truthing for model training.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).