An IVDMIA is a device that:
- Combines the values of multiple variables using an interpretation function to yield a single, patient-specific result (e.g., a “classification,” “score,” “index,” etc.), that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, and
- Provides a result whose derivation is non-transparent and cannot be independently derived or verified by the end user.
While the input variables, alone or in combination, might have meaning to the clinician, the clinician could not verify the clinical significance of the IVDMIA result on his or her own. In addition, the ordering physician cannot reach the IVDMIA result on his or her own, nor could he or she independently interpret that result. The ordering clinician requires information from the test developer, rather than generally accepted information from the clinical community, in order to interpret the IVDMIA result for use in the management of the patient. For an IVDMIA, it is the single patient-specific result that is associated with the intended use of the device. The IVDMIA device includes all elements necessary for obtaining the result.