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Technical assessment form

M00116 2025

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The document is a Technical Assessment (TA) Summary Form (M00116) that outlines the requirements for summarizing evidence related to the validation of a medical test. It includes detailed tables for documenting test-specific information, validation elements, and relevant guidance documents. Key areas covered include accuracy, precision, analytical sensitivity, clinical validity, and utility of the test, along with instructions for providing experimental design descriptions and final results. Additionally, it specifies required elements such as analytical reports and documentation for regulatory approvals.

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