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The Anti-Gliadin (GAF-3X) ELISA (IgG) test kit is intended for the qualitative or semi-quantitative 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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The provided text is an FDA 510(k) clearance letter and an "Indications for Use" statement for the EUROIMMUN US INC. Anti-Gliadin (GAF-3X) ELISA (IgG) device. It does NOT contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text.

The document indicates that the device has received 510(k) clearance based on its substantial equivalence to a legally marketed predicate device. This type of clearance does not typically involve the detailed performance study and acceptance criteria reporting that you are asking for in the same way a PMA (Pre-Market Approval) submission would, or as you might see for a diagnostic AI/ML device where performance metrics against a defined ground truth are central.

To answer your questions, one would need to access the actual 510(k) submission document (K083053), which would contain the performance data and the comparison to the predicate device that led to the substantial equivalence finding.

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