(71 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to the predicate device (INOVA QUANTA Lite™ PR-3) | Demonstrated comparability through: |
| - Comparison study analyzing positive, equivocal, and negative sera | - Data show comparability in results for positive, equivocal, and negative sera with the predicate. |
| - Results obtained for externally defined Calibrators and clinically defined sera | - Data show comparability in results for externally defined calibrators and clinically defined sera with the predicate. |
| - Results obtained for samples from apparently healthy subjects (normal population) | - Data show expected results for samples from apparently healthy subjects. |
| Performance according to state-of-the-art expectations and medical literature | "the assay performs as expected from the medical literature" and "performs according to state-of-the-art expectations." |
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.
§ 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).