(81 days)
The Varelisa ß2-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgA antibodies in serum or plasma.
The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
The Varelisa B2-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgA antibodies in serum or plasma.
The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
Here's an analysis of the provided text regarding the Varelisa® ß2 Glycoprotein I IgA Antibodies device, structured to address your specific questions about acceptance criteria and study details.
Please note: The provided text is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data with detailed acceptance criteria and standalone studies in the way a PMA might. As such, some of your requested information (e.g., specific quantitative acceptance criteria, standalone performance details, MRMC study results) is not explicitly present in the provided document. I will extract what is available and indicate when information is not provided.
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary describes laboratory equivalence to a predicate device. It does not explicitly state quantitative acceptance criteria in a table format with specific thresholds. Instead, it relies on demonstrating comparable performance to the predicate device and expected behavior based on medical literature.
| Acceptance Criteria (Implied/General) | Reported Device Performance (Summary) |
|---|---|
| Comparability with Predicate Device (INOVA QUANTA Lite™ ß2 GPI IgA) | - Results obtained within a comparison study analyzing positive, equivocal, and negative sera showed comparability. |
- Results for externally defined calibrators showed comparability.
- Results for samples from apparently healthy subjects (normal population) showed comparability. |
| Suitability for Serum and Plasma Samples | - The device is outlined for use with serum and plasma, with corresponding performance data underlining its effectiveness with plasma as a sample. |
| Performance in line with medical literature | - The assay performs as expected from the medical literature regarding the diagnosis of thrombotic disorders related to primary Antiphospholipid Syndrome or secondary to SLE/other autoimmune diseases. |
| Decision Point Evaluation Method | - The Varelisa assay uses an OD cutoff for evaluation, and corresponding performance data show the comparability of results to the predicate device which uses a decision point method. |
2. Sample Sizes and Data Provenance for Test Set
- Sample Size for Test Set: Not explicitly stated as a single number. The document mentions a "data set including results obtained within a comparison study analyzing positive, equivocal and negative sera," and "results obtained for samples from apparently healthy subjects (normal population)." The specific number of samples in these comparison studies is not detailed.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be clinical laboratory evaluations. The document refers to "the medical literature" and "scientific knowledge" as a basis for the intended use and performance expectations, implying a broader, though unspecified, provenance for general knowledge. The manufacturer is based in Germany.
- Retrospective/Prospective: Not explicitly stated. Given it's a 510(k) comparison study, it's often retrospective use of banked samples, but this is not confirmed.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This device is an in-vitro diagnostic (IVD) immunoassay for autoantibodies. The "ground truth" for such devices typically relies on a combination of:
- Clinical diagnosis based on established medical criteria (e.g., for SLE, Antiphospholipid Syndrome).
- Results from a well-characterized predicate immunoassay or reference method.
- Clinical status of patients (e.g., "apparently healthy subjects").
The document does not mention the use of human experts (e.g., radiologists) establishing ground truth in the way it would for an imaging AI device. The ground truth seems to be implicitly derived from the clinical status of the patients and the results of the predicate device.
4. Adjudication Method for Test Set
No explicit adjudication method is described. The "ground truth" for an immunoassay comparison study is usually established by the clinical diagnosis of the patient and/or the result from the predicate device (or a gold standard if available), rather than a panel of expert reviewers adjudicating individual results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study (evaluating human reader performance with and without AI assistance) is relevant for imaging AI devices that assist human interpretation. This device is an immunoassay kit for laboratory use and does not involve human "readers" in the diagnostic interpretation in the same way.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance was done in the sense that the device's performance was evaluated independently and then compared to a predicate device. The comparison studies evaluating "positive, equivocal and negative sera," "externally defined Calibrators," and "samples from apparently healthy subjects" represent evaluations of the device's standalone performance characteristics against expected outcomes or the predicate device. However, a specific "standalone" performance metric like sensitivity/specificity against a definitive gold standard not involving the predicate is not explicitly presented, as the emphasis is on substantial equivalence.
7. Type of Ground Truth Used
The ground truth appears to be a combination of:
- Clinical Status/Diagnosis: The intended use links the presence of antibodies to aiding in the diagnosis of thrombotic disorders related to Antiphospholipid Syndrome, SLE, or other autoimmune diseases. Samples were collected from "apparently healthy subjects" and presumably patients with known clinical conditions.
- Predicate Device Results: The entire study is a "comparison study analyzing positive, equivocal and negative sera" in relation to the predicate device, thereby using the predicate device's established performance as a de facto reference for "truth" in the context of substantial equivalence.
8. Sample Size for the Training Set
This document does not specify a separate "training set" or its size. This is typical for traditional IVDs like immunoassays, where extensive "training" in the machine learning sense is not performed. Assay development involves optimizing reagents, protocols, and cutoffs, which are different from training an ML algorithm on a dataset. The studies described are more akin to verification and validation.
9. How Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm, this question is not applicable. The development and optimization of the immunoassay would rely on established laboratory practices, chemical principles, and clinical samples previously characterized by the predicate device or clinical diagnosis.
§ 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).