Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Example #1.

• RNA Extracted from Whole Blood

Prognostic gene expression assay using RT-qPCR technology to assess long term clinical outcome in IBD (inflammatory bowel disease). The prognostic qualitative assay utilises gene expression data to generate a risk category that correlates with a patient’s risk of experiencing a frequently relapsing disease course. The risk score from the gene expression values is calculated using proprietary software. This prognostic risk score can then be used in conjunction with a patient’s clinical data to tailor the most appropriate course of therapy for an individual.

The Organisation for Professionals in Regulatory Affairs

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Example #2

Total IgE reagent kit

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A two-step immunoassay intended for the quantitative detection of circulating Total IgE and allergen specific IgE in human sera. The total and specific IgE results are used as an aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

The Organisation for Professionals in Regulatory Affairs

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