(43 days)
This is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener's granulomatosis and other vasculitides.
This is an enzyme immunoassay for the detection of antibodies to Proteinase 3 (PR3) in human serum.
The Immuno Concepts RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3 was evaluated for substantial equivalence to the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit. The study involved a comparison of both devices using a diverse set of human serum samples.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria values for relative sensitivity, specificity, and overall agreement. However, the study aims to demonstrate substantial equivalence to the predicate device. The reported performance metrics based on the comparison serve as the de facto demonstration of equivalence.
| Metric | Reported Device Performance (%) |
|---|---|
| Relative Sensitivity | 97.8 |
| Relative Specificity | 98.6 |
| Overall Agreement | 98.4 |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 756 samples (206 samples submitted for ANCA, MPO, PR3 testing, 7 Churg-Strauss syndrome, 18 vasculitis, 25 Wegener's granulomatosis, 261 male blood donors, 239 female blood donors).
- Data Provenance: The origin of the samples (e.g., country) is not explicitly stated. The samples were from patients with specific diagnoses, those submitted for ANCA testing, and blood donors, indicating a mix of clinical and presumably healthy populations. The data appears to be retrospective, collected from existing clinical and donor samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. The comparison is made against a legally marketed predicate device, implying the predicate device's results are used as the reference, rather than independent expert adjudication.
However, for the 8 "false positive" samples identified by the new device, additional immunofluorescence patterns (P-ANCA, C-ANCA) were noted, and patient diagnoses (Wegener's granulomatosis, Churg-Strauss syndrome) were considered. This suggests some level of clinical context or expert review for specific discordant cases, but a formal "ground truth establishment" process by experts is not detailed.
4. Adjudication Method for the Test Set:
No formal adjudication method (e.g., 2+1, 3+1) for the test set is described. The study primarily compares the performance of the new device against the predicate device. For discordant results, especially "false positives" of the new device, immunofluorescence patterns and patient diagnoses were used to provide further context, suggesting a form of retrospective review rather than pre-defined adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed or described. This study focuses on the performance of an in vitro diagnostic test system, not on human readers' interpretive skills with or without AI assistance.
6. Standalone Performance:
Yes, a standalone performance study was conducted. The Immuno Concepts RELISA® PR3-ANCA Test System was tested independently on the 756 samples, and its results were then compared to those of the predicate device. The performance metrics (relative sensitivity, specificity, overall agreement) reflect the standalone performance of the new device in relation to the predicate.
7. Type of Ground Truth Used:
The "ground truth" for this study is established by the results of the predicate device, the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit. In cases of disagreement, additional clinical information such as immunofluorescence patterns and patient diagnoses were considered to analyze potential "false" results, implying a form of expert or clinical consensus interpretation for discordant cases.
8. Sample Size for the Training Set:
The document describes a comparison study against a predicate device and does not mention a separate training set. This suggests that the device being studied (Immunoconcepts RELISA PR3-ANCA) was likely developed using its own internal development/training data, which is not disclosed in this 510(k) submission. The samples described in the study are explicitly designated for the comparison or test phase.
9. How the Ground Truth for the Training Set Was Established:
As no training set is discussed in this document, the method for establishing its ground truth is not provided.
§ 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).