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The GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from salva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR).

The GlutenID Celiac GHR Test is indicated for reporting of one variant associated with the HLA-DQ2.5 haplotype, one variant associated with the HLA-DQ8 haplotype, one variant associated with the HLA-DQ7 haplotype, and three variants associated with the HLA-DQ2.2 haplotype. The report describes if a person has variants linked to haplotypes associated with an increased risk for developing celiac disease, but it does not describe a person's overall risk of developing celiac disease. This report is most relevant for people of European descent.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the "GlutenID Celiac Genetic Health Risk Test" does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.

The letter is a formal notification of clearance, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as:

• The trade name and regulation details.
• General controls provisions and additional controls for Class II/III devices.
• Applicable regulations like Quality System (QS), Medical Device Reporting (MDR), and Unique Device Identification (UDI).
• Contact information for the FDA.
• The Indications for Use statement.

The document does NOT include information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, their provenance, or whether they were retrospective/prospective.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was performed or its effect size.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

This kind of detailed study information is typically found in the 510(k) submission itself, often in a more extensive "Summary of Safety and Effectiveness" or a dedicated study report, which is not part of this specific FDA clearance letter.

Therefore, I cannot fulfill your request based solely on the provided text.

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