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The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from an EDTA or citrate anticoagulated whole blood sample. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand- alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

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This document is a 510(k) clearance letter for a medical device called the xTAG® CYP2D6 Kit v3. It indicates the device is substantially equivalent to legally marketed predicate devices. However, it does NOT contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets them.

The letter primarily covers the regulatory approval of the device and its intended use. It does not include:

• A table of acceptance criteria and reported device performance: This sort of data would typically be found in the 510(k) summary or the pivotal study report, not in the clearance letter itself.
• Sample sizes used for the test set and data provenance: Again, this detailed study information is not part of the clearance letter.
• Number of experts and their qualifications for ground truth: This pertains to the study design, not the FDA's regulatory decision letter.
• Adjudication method for the test set: Study design detail absent from this document.
• MRMC comparative effectiveness study details (effect size): This device is a genotyping kit, not an AI-assisted diagnostic imaging device for human readers, so an MRMC study with human readers would not be relevant or performed.
• Standalone algorithm performance: This is a lab kit, not an "algorithm" in the sense of AI software. Its performance is evaluated biochemically/molecularly.
• Type of ground truth used: While the ground truth for genetic testing is typically highly reliable reference methods (e.g., Sanger sequencing, alternative validated genotyping assays), the clearance letter doesn't specify this for this particular study.
• Sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set in that context.
• How ground truth for the training set was established: Not applicable.

In summary, the provided document does not contain the information requested in your prompt regarding acceptance criteria and study details. To find this information, you would typically need to consult the 510(k) summary submitted by the manufacturer to the FDA, which often contains a more detailed description of the performance studies.

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