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The Anti-Gliadin (GAF-3X) ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

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This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically an ELISA test. These types of clearances typically do not involve the kind of AI/ML performance acceptance criteria and study designs described in the prompt. The information requested, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance for AI, are not applicable to the clearance of this type of device.

Instead, for IVD devices like the Anti-Gliadin (GAF-3X) ELISA (IgA), the acceptance criteria and supporting studies usually focus on analytical performance (e.g., sensitivity, specificity, accuracy against a predicate device or clinical diagnosis), precision, linearity, and interference studies.

Therefore, I cannot provide the requested information in the format of the prompt because it describes criteria and studies relevant to AI/ML medical devices, not to an ELISA test cleared via a 510(k) pathway as described in the provided document.

The document indicates:

• Device Name: Anti-Gliadin (GAF-3X) ELISA (IgA)
• Intended Use: Qualitative determination of IgA class antibodies against gliadin in human serum as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
• Regulatory Class: II
• Product Code: MST
• Predicate Device: Not explicitly detailed in the provided excerpt, but it is implied that the device demonstrates substantial equivalence to a legally marketed predicate.

To provide information analogous to the prompt's request for an IVD ELISA test, one would look for data on diagnostic sensitivity, specificity, and agreement with a reference method or predicate device, typically found in the 510(k) summary if available, or the full submission. However, this level of detail is not present in the provided FDA clearance letter itself.

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