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- W2959131799 abstract "Abstract An in vitro diagnostic (IVD) device can only be useful if it can satisfy its analytical, clinical, and regulatory expectations and its levels depend on the possible impact of results on medical decision and the device analytical complexity. In the United States, FDA regulates devices, and CLIA (Clinical Laboratory Improvement Amendments) is meant to oversee laboratory operational aspects; however, CLIA has been, also, overseeing tests developed and run by laboratories, which are commonly known as laboratory-developed tests. FDA and CLIA classify IVDs into classes (Class I, II, and III and waived, moderate, and high complex) depending on their complexities, liability to errors, possible impact of erroneous results, and level of regulatory control needed. No IVD is absolutely perfect, and one has to employ an assay with acceptable analytical performance characteristics." @default.
- W2959131799 created "2019-07-23" @default.
- W2959131799 creator A5037455342 @default.
- W2959131799 date "2019-01-01" @default.
- W2959131799 modified "2023-10-18" @default.
- W2959131799 title "Essential attributes of an acceptable in vitro diagnostic test" @default.
- W2959131799 doi "https://doi.org/10.1016/b978-0-12-816121-0.00005-2" @default.
- W2959131799 hasPublicationYear "2019" @default.
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