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The FIDIS™ THYRO kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against thyroperoxydase (TPO) and thyroglobuline (TG).

Clinical utility:

The test system is used on serum samples as an aid in the diagnostic of auto-immune thyroid pathologies (Graves' disease and Hashimoto thryroiditis), in conjunction with clinical findings and other laboratory tests.

The FIDIS™ THYRO kit is to be used on FIDIS™ Analyser, software and washer.

The assay kits consist of:

• a vial of color-coded microsphercs coupled with thyroperoxydase (TPO) or thyroglobulin (TG)

• a ready to use anti-human IgG coupled to phycocrythrin,

• a ready to use calibrator titered for the specificity,

• a 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 FIDIS™ kits and a software MLX-BOOSTER.

The FIDIS™ THYRO kit resembles traditional EIA and allows the detection and identification of antibodies against thyroperoxydase (TPO) and thyroglobuline (TG).

• 1. Diluted patient sera and microsphere suspension are thoroughly mixed in the 96 well microtiter plate. TPO or TG specific antibodies in the patient sera, if present, bind to the immobilised antigen on the beads. Any unbound material is removed by performing a wash step.
• 2. Phycoerythrin-conjugated goat anti-human IgG is added to the plate and a further incubation performed. The conjugated anti-human IgG binds to the TPO or TG specific antibodies immobilised on the microsphere surface to form an antigen/antibody complex.
• 3. The bead suspension is then analysed by the FIDIS™ Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER).
     The FIDIS™ Instrument is able to distinguish the specific color-coded of the microsphere 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.

The provided document is a 510(k) Premarket Notification for the FIDIS™ THYRO device. It details the device's intended use, technological characteristics, and comparison to predicate devices, focusing on establishing substantial equivalence. However, it does not contain the specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria, nor does it provide information on sample sizes, ground truth establishment, or expert involvement in the manner requested.

The document states:

• "The comparability of predicate devices and new devices is supported by 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"
• "In conclusion, all available data support that the new devices, FIDIS™ THYRO kit is substantially equivalent to the predicate devices."

This indicates that studies were performed, but the specifics of those studies (e.g., acceptance criteria, detailed performance metrics, sample sizes, ground truth methodology) are not included in this summary.

Therefore, I cannot populate the requested table or provide the detailed study information based solely on the provided text. The document serves as a high-level summary for regulatory submission rather than a detailed study report.

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