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The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent based microparticles immunoassay using flow cytometry readings. It is designed for the simultaneous detection of autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm. Sm/RNP, Scl-70, Jo-1 ribosome and centromere in human serum. (* Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).

The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.

The assay kits consist of:

• a mixture of color-coded microspheres sensitized respectively by dsDNA, SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes and Centromeres.
• a ready to use anti-human IgG coupled to phycoerythrin,
• a ready to use calibrator titered for each 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 assay products and a MLX-BOOSTER software.

The FIDIS™ CONNECTIVE 10 kit resembles traditional EIA, but allows simultaneous detection and identification of several antibodies in a single well.

• 1. Diluted patient sera and multiplexed bead suspension are thoroughly mixed in the 96 well microtiter plate. Antigen specific antibodies in the patient sera, if present, bind to the immobilised antigen on one or more of the bead sets. 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 antigen 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-code of each microsphere types and it could associate the microsphere type with the individual tested antigen.
The FIDIS™ Instrument can 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.

Here's a summary of the acceptance criteria and the study details for the FIDIS™ CONNECTIVE 10 device, based on the provided text:

Premarket Notification 510(k) Summary for FIDIS™ CONNECTIVE 10 (K053653)

The document primarily focuses on establishing substantial equivalence to predicate devices, rather than defining specific numerical acceptance criteria for performance metrics like sensitivity and specificity. The acceptance criteria appear to be implicit in demonstrating comparability to the predicate devices across various sample types.

1. Table of Acceptance Criteria and Reported Device Performance

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

The exact sample sizes for the test set (comparison study, healthy subjects, cross-reactivity samples) are not specified in this summary document.
The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) test for autoantibody detection, not an imaging device requiring human reader interpretation in the same way.

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

The device is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is an automated system for immunodiagnostic testing. The "standalone" performance is inherent to its function as an IVD device, where the instrument performs the detection and quantification. The summary describes the assay steps culminating in analysis by the FIDIS™ Instrument which calculates results using specific software. Therefore, the reported performance is a standalone (algorithm/instrument only) performance.

7. The Type of Ground Truth Used

The ground truth for the comparison studies is implicitly based on the results obtained from legally marketed predicate devices. The summary states the comparison included "positive, equivocal and negative sera" and "samples from apparently healthy subject (normal population)" and "samples with potential biological cross reactivity." This suggests that the ground truth for these samples was likely established through existing clinical diagnoses and reference methods (including the predicate devices themselves) based on a combination of clinical findings, other laboratory tests, and potentially expert consensus on patient status.

8. The Sample Size for the Training Set

The document does not provide information on a separate "training set" or its sample size. For IVD devices, the characterization of reagents and assay parameters during development might be analogous to "training," but the summary does not detail this.

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

Since no separate training set is explicitly mentioned, there is no information on how its ground truth was established.

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