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Celikey is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgA antibodies in human serum and plasma. Celikey is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease.

Celikey is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of IgA antibodies against Tissue transglutaminase in human serum or plasma.

The test kit contains microplate strips coated with purified human recombinant tTG antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.

Acceptance Criteria and Device Performance Study for Celikey® Tissue Transglutaminase (human, recombinant) IgA Antibody Assay

This response details the acceptance criteria and the study performed to demonstrate the Celikey® Tissue Transglutaminase (tTG) IgA Antibody Assay meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list specific quantitative "acceptance criteria" in a table format with numerical targets for sensitivity, specificity, or agreement with a gold standard. Instead, it focuses on demonstrating substantial equivalence to a predicate device (INOVA QUANTA Lite™ tTG) and that the assay performs "as expected from the medical literature."

Therefore, the acceptance criteria are implicitly based on the predicate device's performance and general expectations for diagnostic tests for celiac disease, expressed as data showing comparability and expected performance.

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

• Sample Size: The document does not explicitly state the exact sample size for the test set used in the comparison study or for the clinically defined and normal population sera. It refers to a "data set including" these categories of results.
• Data Provenance: The document does not specify the country of origin of the data. It indicates the data includes:
  • Results obtained within a comparison study analyzing positive, equivocal, and negative sera.
  • Results obtained for clinically defined sera.
  • Results obtained for endemic and any and any subjects (normal population).
• Retrospective or Prospective: Not explicitly stated, however, the description of "results obtained" typically suggests retrospective analysis of collected samples, but this cannot be definitively confirmed from the provided text.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set. The ground truth for "clinically defined sera" would typically rely on clinical diagnosis by medical professionals, but this is not elaborated upon.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set. The evaluation seems to rely on direct comparison of results between the new device and the predicate, and against expected outcomes for clinically defined samples.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers interpreting diagnostic images or data with and without AI assistance, which is not applicable to this in-vitro diagnostic device (immunoassay). The study performed was a laboratory equivalence study comparing the new device to a predicate device.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done. The "results obtained for clinically defined sera" and "results obtained for endemic and normal population subjects" constitute the standalone performance evaluation of the Celikey® assay itself, demonstrating its ability to distinguish between different clinical states, even if in comparison to the predicate and medical literature expectations. The device is an immunoassay that provides a quantitative or semi-quantitative result directly, without requiring human-in-the-loop interpretation for its primary output.

7. Type of Ground Truth Used

The type of ground truth used appears to be a combination of:

• Predicate Device Results: For the "comparison study analyzing positive, equivocal and negative sera," the predicate device's results likely served as a reference or a comparative ground truth.
• Clinical Diagnosis/Medical Literature: For the "clinically defined sera" and "endemic and normal population subjects," the ground truth was based on the clinical diagnosis of the patients (e.g., diagnosed celiac disease patients vs. healthy controls) and general medical understanding of tTG IgA antibody levels in these populations. This indirectly points to clinical outcomes as the ultimate ground truth, but the direct evidence for the study was likely established diagnoses.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. Immunoassays like this do not typically involve a "training" phase in the same way machine learning algorithms do. The development of such assays involves optimizing reagents and protocols, but the concept of a "training set" with established ground truth for an algorithm is not applicable here.

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

As no training set is mentioned or applicable in the context of this device's development as described, there is no information on how its ground truth was established.

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