(55 days)
The Varelisa MPO ANCA EIA kit is designed for the semi-quantitative and qualitative determination of myeloperoxidase anti neutrophil cytoplasmatic antibodies (MPO ANCA) in human serum or plasma to aid in the diagnosis of certain autoimmune vasculitides such as microscopic polyangiitis, and crescentic glomerulonephritis.
Varelisa MPO ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of MPO ANCA in human serum or plasma. Antibodies specific for MPO present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with human purified MPO ANCA 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 regarding the Varelisa® MPO ANCA device, presented in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed list of specific acceptance criteria with numerical targets. Instead, it offers a general statement about "comparability" and "expected performance."
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance |
|---|---|---|
| Comparability | Assay performs as expected compared to predicate device and medical literature. | "The data show that the assay performs as expected from the medical literature." |
| Performance (General) | "Substantially equivalent" to predicate device. | "all available data support that the new device, PHARMACIA Varelisa MPO ANCA Assay is substantially equivalent to the predicate device, INOVA QUANTA Lite™ MPO Assay" and "performs according to state-of-the-art expectations." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for the test set used in the comparison study. It mentions a "data set including: results obtained within a comparison study analyzing positive, equivocal and negative sera; results obtained for externally defined Calibrators and clinically defined sera; results obtained for samples from apparently healthy subjects (normal population)."
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document is from Pharmacia Deutschland GmbH, suggesting the studies likely originated in Germany or Europe, but this is not confirmed. The studies appear to be retrospective as they are described as "results obtained" from existing samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information about the number or qualifications of experts used to establish a ground truth for the comparison study. The "ground truth" seems to be implied by existing clinical classifications (positive, equivocal, negative sera) and "clinically defined sera," but the method of definition is not detailed.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described compares the performance of a new diagnostic device (Varelisa MPO ANCA) against a predicate device (INOVA QUANTA Lite™ MPO) using patient samples, not evaluating human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The Varelisa MPO ANCA is an in vitro diagnostic immunoassay Kit, meaning its performance is evaluated as a standalone biological/chemical assay without human interpretation as part of its core function, other than laboratory personnel following the kit instructions. The comparison study assesses the kit's direct analytical output.
7. The Type of Ground Truth Used
The ground truth used appears to be a combination of:
- Clinical Definition/Classification: "positive, equivocal and negative sera" and "clinically defined sera" imply a pre-existing clinical diagnosis or classification for the samples.
- Reference Method Comparison: Implied by the comparison to the "INOVA QUANTA Lite™ MPO," which serves as the predicate device (and thus a de facto reference for comparison in this context).
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI models. This device is an immunoassay kit, which is a chemical/biological test system, not an AI or machine learning algorithm that requires training data in the conventional sense. The "training" in this context would be the development and optimization of the assay reagents and protocol.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the machine learning sense for this immunoassay device, the concept of establishing ground truth for a training set does not apply. The development of the kit would involve internal validation and optimization, but this is distinct from establishing ground truth for an AI training set.
§ 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).