(81 days)
The Varelisa B2-Glycoprotein I IgG Antibodies EIA kit is designed for the semiguantitative and qualitative determination of ß2-glycoprotein I IgG antibodies in serum or plasma.
The presence of ß2-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.
Varelisa B .- Glycoprotein I IgG Antibodies Assay is an indirect The noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ß2-glycoprotein I IgG 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.
The provided text describes the Varelisa® ß2 Glycoprotein I IgG Antibodies EIA kit and its comparison to a predicate device, but it lacks specific acceptance criteria as quantitative thresholds and a detailed study report that explicitly states how these criteria were met.
However, based on the provided text, I can infer the implied acceptance criteria, the general nature of the study conducted, and the reported device performance.
Here's an analysis of the information requested, based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it focuses on the comparability to a predicate device and performance as expected from medical literature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: | |
| - Comparable performance to INOVA QUANTA Lite™ ß2 GPI IgG Assay for semi-quantitative and qualitative determination of IgG antibodies against ß2-glycoprotein I in serum. | - "The comparability of QUANTA LiteTM B2 GPI IgG and Varelisa B2-Glycoprotein I IgG Antibodies is supported by a data set including results obtained within a comparison study analyzing positive, equivocal and negative sera." |
- "Corresponding performance data show the comparability of the results" (referring to OD-cutoff vs. decision point method for evaluation).
- "All available data support that the new device...is substantially equivalent to the predicate device." |
| Suitability for Intended Use (Serums & Plasma): | |
| - Effective for use with serum samples. | - "The data show that the assay performs as expected from the medical literature." |
| - Effective for use with plasma samples. | - "Corresponding performance data underline the effectiveness of the assay with plasma as sample." - "The data show that the device is suitable for serum and plasma samples." |
| Accuracy/Reliability (General): | |
| - Performs as expected from medical literature. | - "The data show that the assay performs as expected from the medical literature." - "The new device performs according to state-of-the-art expectations." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "a comparison study analyzing positive, equivocal and negative sera" and "results obtained for samples from apparently healthy subjects (normal population)," but no specific numbers of samples are provided for these test sets.
- Data Provenance: Not explicitly stated. The manufacturer is based in Germany (Pharmacia Deutschland GmbH), suggesting the study could have been conducted in Germany, but this is not confirmed. It is a retrospective or prospective study is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The method for establishing ground truth for the comparison study is not detailed.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable here. This device is an in vitro diagnostic (IVD) immunoassay kit for laboratory analysis, not an AI-assisted diagnostic tool that helps human readers (e.g., radiologists) interpret images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as it's an IVD kit, not an algorithm that operates independently without human interaction (even lab technicians are "in the loop" for running the test and interpreting the results within the context of the patient's clinical picture). The device itself is the "standalone" diagnostic tool in a lab setting, providing a semi-quantitative or qualitative result.
7. The type of ground truth used
The type of ground truth is implied to be clinical diagnosis or established antibody status. The mention of "positive, equivocal and negative sera" suggests that the samples had a pre-determined status based on clinical findings, other laboratory tests, or established reference standards for ß2-glycoprotein I IgG antibodies. The intended use statement also highlights its role "in conjunction with clinical findings and other laboratory tests to aid in the diagnosis," which points towards clinical correlation as the ultimate ground truth.
8. The sample size for the training set
This information is not provided in the document. The document describes a comparison study, but not a distinct "training set" in the context of machine learning or algorithm development. The development of the immunoassay itself would involve internal validation and optimization, but the term "training set" is not used or detailed.
9. How the ground truth for the training set was established
As no training set is explicitly mentioned, how its ground truth was established is not discussed in the document.
§ 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).