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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to gliadin in human serum.

Uses:

The results of the anti-gliadin IgA assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies including Coeliac Disease.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

The assay may be used on the Hycor Hy•Tec Automated EIA instrument.

For in vitro diagnostic use only.

Not Found

I am sorry, but the provided text does not contain enough information to fulfill your request. The document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, "Autostat™ II Anti-Gliadin IgA ELISA."

While it mentions the intended use of the device as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies (including Coeliac Disease), it does not provide any details about:

• Acceptance criteria: What specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, correlation) were established and what values were set as acceptable.
• Reported device performance: The actual results from any studies demonstrating these performance metrics.
• Study design details: Such as sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or whether standalone or MRMC studies were conducted.

The document primarily focuses on the FDA's determination of substantial equivalence and regulatory classification, not on the detailed technical or clinical study results that would typically include acceptance criteria and performance data.

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