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The FIDIS™ CELIAC kits are quantitative homogeneous fluorescent-based microparticles immunoassays using flow cytometry readings. They are designed for the simultaneous detection of human isotype IgA and/or IgG autoantibodies directed against Gliadin and tissue Transglutaminase Enzyme.

The presence of tissue Transglutaminase and Gliadin autoantibodies can be used to aid in the diagnosis of Celiac disease.

The FIDIS™ CELLAC kit is a semi-quantitative homogencous fluorescent-hased microparticles immunoassay using flow cytometry readings. It is designed for the simultancous detection of human isotype IgA or IgG antibodies directed against Gliadin and tissue Transglutaminase Enzyme.

Clinical utility:

The presence of these antibodies can be used in conjunction with clinical findings to aid in diagnosis of Celiac disease. The FIDIS™ CELIAC kit is to be used in serum only

The FIDISTM CELIAC Kits are to be used on FIDISTM Analyzer, software and washer.

The assay kits consist of:

• a mixture of color-coded microspheres respectively sensitized by Gliadin (Glia) or tissue transglutaminase (tTG),

• a ready to use phycoerythrin conjugated anti-human IgA or phycoerythrin conjugated anti-human IgG.

• a ready to use calibrator IgA or calibrator IgG,

• a positive control IgA or positive control IgG to be diluted,

• a negative control to be diluted.

• a 10X concentrated PBS-Tween.

Rk: Calibrators, positive and negative controls are diluted human sera.

The FIDIS™ System is a fully integrated and automated system for immunodiagnostic testing.

FIDIS™ System comprised of FIDIS flow cytometer, XYP platform for automatic sampling into the analyser, the analyzer itself, a SD pump, some assay products and a software MLX-BOOSTER.

The FIDIS™ CELIAC kits resemble traditional EIA, but allow simultaneous detection and identification of several antibodies in a single well.

The serum sample is combined with a mix of microspheres individually coated with gliadin or tTG and form an antigen / antibody complex.

After washing, this complex is incubated with phycoerythrin labeled anti-human IgG or IgA. If autoantibodies are present in the sample, the final sandwich complex antigen / human antibody / anti-human antibody will form.

Reactions are directly analysed by the cvtometer and calculated in biological units using specific data software (MLX-BOOSTER).

The FIDIS™ Instrument is able to distinct the specific color-coded of each microsphere types and it could associated the microsphere type with the individual tested antigen.

The FIDIS™ Instrument could quantify the fluorescence of the antibody captured by each microsphere. Measurement of the fluorescent signal from the final reaction complex allows the quantification of the presence or absence of autoantibodies.

It's a simple (just two steps), quick (2 x 30 minutes for the two incubations) and multiple parameter test.

This document is a 510(k) Premarket Notification Summary for the FIDIS™ CELIAC kits. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving device performance in the way you've outlined for diagnostic AI/medical device studies.

Specifically, the document does not provide:

• A table of acceptance criteria with specific thresholds for performance metrics (e.g., sensitivity, specificity, accuracy).
• Reported device performance metrics against those specific acceptance criteria.
• Sample sizes used for a "test set" in the context of an independent validation, nor data provenance details like country of origin or whether data was retrospective/prospective for such a validation.
• Information about the number or qualifications of experts used to establish ground truth for a test set.
• Adjudication methods.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes of human readers with/without AI assistance.
• Standalone algorithm performance data.
• Details about the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for a specific test set.
• Sample size for a "training set" (as this is a diagnostic assay, not an AI algorithm) or how ground truth was established for it.

Instead, the document focuses on:

• Identification of the device: FIDIS™ CELIAC kits (IgA and IgG assays for gliadin and tTG).
• Intended Use: Aid in the diagnosis of Celiac disease by detecting IgA and/or IgG autoantibodies.
• Description of the device: A quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry.
• Predicate Devices: Lists several INOVA Diagnostics and Sweden Diagnostics kits.
• Summary of technological characteristics: Compares the FIDIS™ System to traditional EIAs, highlighting its ability for simultaneous multi-antibody detection and automated analysis.
• Testing: Mentions "a data set including: results obtained within a comparison study analysing positive, equivocal and negative sera; results obtained for samples from apparently healthy subject (normal population); results obtained for samples from samples with potential biological cross reactivity." This is a high-level description and lacks the specific quantitative performance data you're requesting.
• Conclusion: States that the new devices are "substantially equivalent to the predicate devices."

Therefore, based on the provided document, I cannot fulfill your request for a detailed table of acceptance criteria, reported performance against those criteria, or the specific study details (sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance) typically associated with modern device validation studies, especially those involving AI or detailed clinical outcomes.

The document is a regulatory submission demonstrating substantial equivalence to existing diagnostic devices, not a detailed performance study with explicit acceptance criteria and corresponding results as might be found in a peer-reviewed publication or a more comprehensive technical report.

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