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In-vitro Diagnostic Medical device carry out screening, diagnosis, prognosis, predictive testing, and monitoring of conditions outside the body using specimens like blood, tissue or urine with the help of devices like test strips, reagents, analyzers and other assays.
The intended user is not directly exposed to the device and hence not directly affected by the risks of performance testing other than the risk associated with specimen collection procedures. Hence the performance and risk characteristics of IVD medical device IS different and unique from other medical devices.
However, IVD devices still hold information which are critical to patient management, diagnosis and treatment and hence it becomes obligatory to assess the performance and safety of such devices. There are certain tests that can be performed in-house and verified in every manufacturing batch and there are other tests that need to performed and verified in any accredited external testing set-up. Now such tests may include analytical performance testing, clinical performance testing and where the IVD device is associated with an active device, testing related to electrical safety of the IVD device becomes mandatory.
The analytical performance testing aims to establish or confirm the ability of an IVD medical device to detect or measure a particular analyte. It can include assessing the analytical sensitivity (e.g. limit of detection), analytical specificity (e.g. interference, cross-reactivity), accuracy (derived from trueness and precision), linearity, etc.
The other type of study includes clinical performance testing which evaluates the ability of an IVD medical device to yield results that are correlated with a particular clinical condition or physiological/pathological process/state in accordance with the intended use (clinical test purpose, target population and intended user). In accordance with intended use, clinical performance can include expected values, diagnostic sensitivity and diagnostic specificity based on the known clinical condition or physiological/pathological process/state of the individual, and negative and positive predictive values based on the prevalence of the disease.
These tests are to be performed aligning to the requirements specified in internationally accepted standards and guidelines from accredited laboratories.
The list of such tests to be conducted is non-exhaustive and depending on the nature of the device can differ. The ultimate aim is to prove the safety and performance of the device.