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The FIDIS™ dsDNA kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against double stranded DNA (dsDNA).

Clincal unlity:

The test system is used on serum samples as an aid in the diagnostic of systemic lupus erythematosus (SLE), in conjunction with clinical findings and other laboratory tests.

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

The assay kits consist of

• a vial of color-coded microspheres coupled with dsDNA
• a ready to use anti-human IgG coupled to phycoerythrin.
• a ready to use calibrator littered for the specificity.
• a positive control lgG 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 invmunodiagnostic lesting

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

The IIIDIS™ dsDNA kit resembles traditional EIA and allows the detection and identification of antibodies against dsDNA

• i . Diluted patient sera and microsphere suspension are thoroughly mixed in the 96 well microtiter plate. dsDNA specific antibodies in the patient sera, if present, bind to the immobilised untigen on the beads. Any unbound material is removed by performing a wash step.

• 2. Phycoerythrin-conjugated goal anti-human IgG is added to the plate and a further antibedies, immentiliand antibodies immobilised on the microsphere surface to form an antigen/antibody complex
• 3. The bead suspension is then analysed by the FIDISTM Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER)
     The FIDIS™ Instrument is able to distinct the specific code-colored of the microsphere and it could associated the microsphere type with the individual tested antigen. The FIDIS™ Instrument could quantify the finorescente of the antibody captured by
     each microsphere. Measurent of the finorescence of the antibody captured by
     allows the overl allows the quantification of the presence or absence of autoantibudies m

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

The provided document is a 510(k) summary for the FIDIS™ dsDNA kit, a semi-quantitative immunoassay for detecting antibodies directed against double-stranded DNA, used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). This summary focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a novel device. Therefore, much of the requested information, particularly regarding specific numerical acceptance criteria, detailed study results against those criteria, and information about expert consensus, is not explicitly present in the document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense. Instead, it relies on demonstrating substantial equivalence to a predicate device (Varelisa dsDNA antibodies by Sweden Diagnostics, GMH). The "performance" is reported in terms of comparability with this predicate device.

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

• Test Set Sample Size: The document mentions "results obtained within a comparison study analysing positive, equivocal and negative sera," and "results obtained for samples from apparently healthy subject (normal population)," and "samples with potential hiological cross reactivity." However, the exact number of samples used in these studies is not specified.
• Data Provenance: Not explicitly stated. The document indicates the device manufacturer (Biomedical Diagnostics S.A.) is located in France, suggesting the studies could have been conducted there or in other European countries. It is not specified if the data is retrospective or prospective.

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

This information is not provided in the document. The method for establishing "ground truth" (e.g., expert diagnosis, clinical outcomes) is also not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned in the document. The focus is on the device's performance as an immunoassay, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study

The FIDIS™ dsDNA kit itself is the "algorithm" in this context (an immunoassay performed by an automated system). The comparability study described is essentially a standalone performance assessment against a predicate.

• "results obtained within a comparison study analysing positive, equivocal and negative scra ."
• "results obtained for samples from apparently healthy subject (normal population)"
• "results obtained for samples from samples with potential hiological cross reactivity"
  While not using the term "standalone study," the various testing methods described are designed to evaluate the device's performance characteristics on its own.

7. Type of Ground Truth Used

The document describes the device as a "detection test of autoantibodies directed against double stranded DNA (dsDNA)" that "can be used to aid in the diagnosis of SLE." This implies that the 'ground truth' for evaluating the test performance would likely be based on:

• Clinical diagnosis of SLE: Established by clinical findings and other laboratory tests, against which the presence/absence of dsDNA antibodies would be evaluated.
• Predicate device results: As the primary comparison is with the "Varelisa dsDNA antibodies" predicate, the results from this established test would serve as a comparative standard.
  The exact methodology for establishing the ground truth is not explicitly detailed (e.g., whether it relied on specific clinical criteria for SLE diagnosis, or primarily on concordance with the predicate).

8. Sample Size for the Training Set

This information is not provided. As a diagnostic kit, the concept of a "training set" in the context of machine learning algorithms may not directly apply. If assay parameters were optimized, the details of that process (including sample sizes) are not given.

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

This information is not provided.

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