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The Gliadin IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of gastrointestinal disorders, mainly Coeliac Disease. This test is for in vitro diagnostic use.

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This document is a 510(k) clearance letter from the FDA for a device called "The APTUS (Automated) Application of the Gliadin IgG ELISA Test System". As such, it does not contain the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness data.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These details would be found in the 510(k) submission itself, not in the clearance letter.

The clearance letter only states that the device is "substantially equivalent" to legally marketed predicate devices for the indicated use: "The Gliadin IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of gastrointestinal disorders, mainly Coeliac Disease. This test is for in vitro diagnostic use."

To answer your questions, I would need to review the actual 510(k) submission (K993250) made by Zeus Scientific, Inc., which is not provided in the given text.

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