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The QUANTA Lite™ Gliadin IgG II is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of gliadin IgG antibodies in human serum. The presence of gliadin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease.

The QUANTA Lite™ Gliadin IgG II is an enzyme-linked immunosorbent assay (ELISA).

The provided text is a 510(k) premarket notification letter from the FDA for a device called "QUANTA Lite™ Gliadin IgG II". This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

The document primarily states that the FDA has found the device to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It clarifies the device's indications for use (detection of gliadin IgG antibodies to aid in the diagnosis of celiac disease) and its regulatory classification.

Therefore, I cannot provide the requested information based on the input text. The information needed to answer the questions, such as detailed study results, acceptance criteria, and ground truth methodologies, is typically found in the full 510(k) submission document, not in the FDA's decision letter.

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