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In Vitro Diagnostics

Design of Clinical Studies to Validate Effectiveness
  • Wayne R. Patterson

Abstract

An important category of medical devices, distinct from the therapeutic products described and discussed in other chapters, are the in vitro Diagnostic Devices (IVDs). IVDs are, by definition of the Food and Drug Administration (FDA), “...those reagents, instruments and systems intended for use in the diagnosis of disease, or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease or its sequelae. Such products are intended for use in the collection, preparation and examination of specimens taken from the human body.” 1 Perhaps more simply defined, IVDs are laboratory instruments, test kits, or reagent systems.

Keywords

Analyte Concentration Clinical Laboratory Standard Test Assay Qualitative Assay Functional Sensitivity 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media New York 1998

Authors and Affiliations

  • Wayne R. Patterson

There are no affiliations available

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