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UniCAP Gliadin IgA/IgG ImmunoCAPTM is a device for the in vitro semi-quantitative measurement of IgA or IgG antibodies specific for gliadin in human serum. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgA/IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease.

UniCAP Specific IgA/IgG is an in vitro test system for the quantitative measurement of antigen specific IgA/IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgA/IgG is bound to the Antigen ImmunoCAP solid phase component of the UniCAP Specific IgA/IgG system. UniCAP Specific IgA/IgG assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

UniCAP Immunodiagnostic System is a fully integrated and automated system for immunodiagnostic testing. UniCAP System is comprised of Instruments (UniCAP 100 Analyzer, Test System Modules and Assay Products (Fluororenzymeimmunoassays for the measurement of IgE, IgA), ImmunoCAP™ Antigens (solid phase components which contain the specific antigens to be measured), and Software Accessories.

UniCAP 100 Analyzer is designed to handle all steps from sample and reagents handling to processing of results. Reagents, requests, samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.

UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software.

UniCAP® 100 RM External Software is intended to be used with a Windowsbased PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer or network server.

UniCAP Specific IgA is a fluoroenzymeimmunoassay for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgA is bound to the Antigen ImmunoCAPTM solid phase component. Specific IgA antibodies in the patient serum or plasma specimen react with the antigens of interest, in this submission. Gliadin, which are covalently coupled to ImmunoCAP.

UniCAP Specific IgG is a fluoroenzymeimmunoassay for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAPTM solid phase component. Specific IgG antibodies in the patient serum or plasma specimen react with the antigens of interest, in this submission, Gliadin, which are covalently coupled to ImmunoCAP.

Here's a breakdown of the acceptance criteria and study details for the UniCAP® Gliadin IgA Assay and UniCAP® Gliadin IgG Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, the study's purpose was to demonstrate "substantial equivalence" to a predicate device. Therefore, the "acceptance criteria" were implied to be a sufficiently high agreement percentage to support substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • IgA Assay: 98 serum samples (positive and negative)
  • IgG Assay: 99 serum samples (positive and negative)
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "collected serum samples," implying retrospective collection for this comparison, though no specific detail is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes a comparison study between two immunoassay devices, not a study where a ground truth was established by human experts. The "ground truth" for this study was essentially the results obtained from the predicate device (ImmuLisa™ Anti-Gliadin IgA Antibody and ImmuLisa™ Anti-Gliadin IgG Antibody ELISA). Therefore, this section is not applicable in the context of expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was a comparison between two immunoassays, and the results were compared for agreement without an adjudication process among human readers.

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

Not applicable. This is a study comparing the performance of two in vitro diagnostic (IVD) devices, not an AI-assisted human reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This study is a standalone performance evaluation of the UniCAP devices. The results obtained from the UniCAP assays were compared directly against the results from the predicate ImmuLisa™ assays. There is no human-in-the-loop component described for the operation or interpretation of these automated immunoassays.

7. The Type of Ground Truth Used

The "ground truth" for this comparative study was the results obtained from the legally marketed predicate devices:

• ImmuLisa™ IgA Anti-Gliadin Antibody (K982533)
• ImmuLisa™ IgG Anti-Gliadin Antibody (K982701)

The study aimed to show substantial equivalence to these established assays, implying their results served as the reference.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device comparison, not an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no apparent training set mentioned in the context of this device.

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