(81 days)
The Varelisa B .- Glycoprotein I Antibodies Screen EIA kit is designed for the qualitative determination of B2-Glycoprotein I antibodies in human 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 ß2-Glycoprotein I Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against ß glycoprotein I in serum or plasma.
The test kit contains microplate strips coated with human purified ß2glycoprotein I. calibrator, negative control, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
The provided text describes a 510(k) summary for a medical device called Varelisa® ß2-Glycoprotein I Antibodies Screen. While it discusses the device's intended use and general performance, it does not explicitly state formal acceptance criteria in a quantifiable manner or detail a specific study designed to "prove" the device meets such criteria to the extent typically expected in a scientific study report.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (INOVA QUANTA Lite™ B2 GPI Screen) through comparative performance data. The "study" mentioned is a "comparison study analyzing positive, equivocal and negative sera," along with results for external calibrators and samples from healthy subjects.
Here's an attempt to extract the requested information based on the provided text, acknowledging limitations due to the nature of the 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) are not explicitly stated in the provided text, this table will represent the general comparative findings presented to establish substantial equivalence.
| Acceptance Criterion (Inferred from Substantial Equivalence Goal) | Reported Device Performance (Varelisa® ß2-Glycoprotein I Antibodies Screen vs. Predicate) |
|---|---|
| Qualitative determination of B2-Glycoprotein I antibodies in human serum. | The new device is "substantially equivalent" to predicate for qualitative determination in serum. |
| Qualitative determination of B2-Glycoprotein I antibodies in human plasma. | Performance data "underline the effectiveness of the assay with plasma as sample," unlike the predicate which is "only recommended for use in serum." |
| Comparability with predicate device across positive, equivocal, and negative sera. | "The comparability... is supported by a data set including results obtained within a comparison study analyzing positive, equivocal and negative sera." |
| Performance with externally defined Calibrators. | "Results obtained for externally defined Calibrators" support comparability. |
| Performance with samples from apparently healthy subjects (normal population). | "Results obtained for samples from apparently healthy subjects (normal population)" support comparability. |
| Performance according to current scientific knowledge regarding B2-glycoprotein I antibodies and antiphospholipid syndrome. | "Intended use... was adapted to the current state of scientific knowledge." The device "performs as expected from the medical literature." |
| OD cut-off method for evaluation. | "Corresponding performance data show the comparability of the results" with the predicate's decision point method. |
Note: The document states, "The data show that the assay performs as expected from the medical literature. Furthermore the performance data show that the device is suitable for serum and plasma samples." This implies that the 'acceptance criteria' were met by demonstrating similar performance to the legally marketed predicate and suitability for both serum and plasma.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The text mentions "a comparison study analyzing positive, equivocal and negative sera," "results obtained for externally defined Calibrators," and "results obtained for samples from apparently healthy subjects (normal population)." However, the specific number of samples in each category tested is not provided.
- Data Provenance: Not explicitly stated (e.g., specific country of origin or whether samples were prospective or retrospective). The manufacturer is based in Germany, so it's plausible the data collection predominantly occurred there or in Europe, but this is not confirmed. The study used "human serum or plasma."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For immunological assays like this, ground truth is typically established by clinical diagnosis, other laboratory tests, or established consensus among medical professionals. The document simply states the device aids in diagnosis "in conjunction with clinical findings and other laboratory tests."
4. Adjudication Method for the Test Set
This information is not provided. The text does not describe any expert adjudication process for the test results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The device is an in-vitro diagnostic (IVD) immunoassay designed for qualitative determination of antibodies, not an imaging device typically assessed with MRMC studies or involving human readers interpreting outputs in such a way. The focus is on the device's accuracy in detecting specific antibodies rather than human interpretation of complex data. Therefore, there is no mention of human readers or an effect size for human improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes. The data presented appears to refer to the standalone performance of the Varelisa® ß2-Glycoprotein I Antibodies Screen device itself, comparing its output to that of the predicate device and potentially to clinical expectations. As an automated immunoassay, its performance is inherently standalone in generating a result, which is then interpreted by a clinician in the context of other findings.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly detailed for the specific comparison study. However, for an immunoassay, the implicit ground truth would typically be established based on:
- Clinical diagnosis: Patients with primary Antiphospholipid Syndrome or SLE.
- Other laboratory tests: Results from established assays for B2-glycoprotein I antibodies or other relevant markers.
- Disease status: Classification of samples as "positive, equivocal and negative sera" implies a prior determination of their status, likely based on a combination of clinical criteria and/or predicate device results.
8. Sample Size for the Training Set
The document is a 510(k) summary for an immunoassay kit. Immunoassays are typically "trained" during their development and optimization phases, but the process is different from machine learning algorithms. The text does not provide any information about a "training set" or its size in the context of device development or any potential algorithm used.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the provided text in the context of a machine learning algorithm, there is no information on how its ground truth would have been established. For traditional immunoassay development, the "ground truth" for calibrator and control materials is established through rigorous internal characterization and standardization, often against reference materials. However, details of this are not included here.
§ 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).