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The Varelisa Gliadin IgG Antibodies EIA kit is designed for the semiquantitative and qualitative determination of gliadin (IgG) antibodies in serum or plasma to aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.

Varelisa Gliadin IgG Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of gliadin (IgG) antibodies in human serum or plasma. Antibodies specific for gliadin (IgG) present in the patient sample bind to the antigen.

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

The provided text describes a 510(k) submission for the Varelisa® Gliadin IgG Antibodies device. However, it does not contain explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity thresholds, or quantitative comparison targets) that the device must meet. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device.

The study presented is primarily a "laboratory equivalence" and device comparison study, rather than a study designed to meet pre-defined, quantitative acceptance criteria.

Here's an attempt to extract and describe the requested information based on the provided text, while acknowledging the limitations of the input regarding explicit acceptance criteria.

Acceptance Criteria and Device Performance Study for Varelisa® Gliadin IgG Antibodies

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, explicit quantitative acceptance criteria (e.g., specific sensitivity/specificity thresholds, agreement percentages) are not provided in the submitted text. The document refers to "substantial equivalence" as the primary goal. The reported device performance is described qualitatively as supporting this equivalence.

• Results obtained for clinically defined sera were comparable.
• Results obtained for samples from apparently healthy subjects (normal population) were comparable.
• All available data support substantial equivalence and performance according to state-of-the-art expectations. |
  | Intended Use | Aid in the diagnosis of certain gluten-sensitive enteropathies (celiac disease, dermatitis herpetiformis) by determining gliadin (IgG) antibodies in serum or plasma. | The device is designed and intended for this purpose, with the difference that the new device supports both serum and plasma, whereas the predicate only supports serum. |
  | Test Principle | Indirect noncompetitive enzyme immunoassay for semi-quantitative and qualitative determination of gliadin (IgG) antibodies. | Both the new device and the predicate device utilize an indirect noncompetitive enzyme immunoassay principle, with comparable antigens and detection systems. |
  | Sample Dilution | Recommend comparable sample dilutions to the predicate. | The new device recommends the same sample dilutions as the predicate device. |
  | Cut-off Determination | Effective classification of results (e.g., negative, equivocal, positive). | The new device uses a set of six calibrators and classifies results as negative, equivocal, and positive. (This differs from the predicate's use of low/high positive standards and grading as negative, weak, moderate, strong positive, but is presented as an alternative, acceptable method). |

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

• Sample Size: The document mentions "a data set including results obtained within a comparison study analyzing positive, equivocal and negative sera," "clinically defined sera," and "samples from apparently healthy subjects (normal population)." However, the specific sample sizes for these test sets are not provided.
• Data Provenance: Not explicitly stated. Given the manufacturer is based in Germany and the submission is to the US FDA, the data could be from Germany or elsewhere. The text does not specify 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 text refers to "clinically defined sera" but does not detail how these definitions were established or by whom. The ground truth for "apparently healthy subjects" is assumed to be based on their health status.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study is not mentioned in the provided text. This type of study typically involves human readers aided by AI vs. without AI, which is not applicable here as the device is a diagnostic assay (an in vitro diagnostic device, not an AI-assisted image interpretation system).

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

• Yes, the testing described is inherent to a standalone device. The Varelisa® Gliadin IgG Antibodies kit is an in vitro diagnostic assay. Its performance is evaluated based on its ability to detect antibodies in serum/plasma samples, independent of human interpretation beyond reading the assay results. The "laboratory equivalence" study assesses the device's inherent performance characteristics.

7. The Type of Ground Truth Used

• The ground truth appears to be based on:
  • Clinical Definition/Classification: "Clinically defined sera" imply a diagnosis or classification based on established medical criteria (though the specific diagnostic criteria for celiac disease or dermatitis herpetiformis are not detailed in this document).
  • Health Status: "Samples from apparently healthy subjects (normal population)" serve as a 'negative' ground truth.
  • Predicate Device Results: The comparison against the predicate device also implicitly uses the predicate's results as a reference point for demonstrating equivalence, though the predicate itself would have been validated against clinical ground truth.

8. The Sample Size for the Training Set

• This submission describes a commercial device and its validation for a 510(k) submission. It does not mention a "training set" in the context of machine learning, as this is a traditional immunoassay, not an AI/ML algorithm. Therefore, this question is not applicable.

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

• As the concept of a "training set" for an AI/ML algorithm is not applicable to this device, this question is also not relevant to the provided document.

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