A significant risk IVD device is generally one that is used for diagnosing, curing, mitigating, or treating disease and presents a potential for serious risk to the health, safety, or welfare of a subject. Potential serious risk is described to be misdiagnosis or error in treatment that results in permanent or fatal damage. This can come in the form of false positive results or false negative results. False positive results can lead to unnecessary treatment or confirmatory testing while false negative results can lead to a delay in establishing the correct diagnosis or delay in treatment.

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