In Vitro Diagnostic definition

In Vitro Diagnostic means: (i) in the United States, an Assay intended for use in the disease prognosis or treatment selection / prediction, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, as more fully defined in 21 C.F.R. § 800 et seq., including so-called complementary diagnostics (e.g., those used to identify patients whose Biomarker status is associated with a changed therapeutic response), companion diagnostics for a pharmaceutical product as defined in FDA’s “Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices”, (ii) in the European Union, an in vitro diagnostic medical device as defined in the European directive 98/79/EC, and (iii) any similar definitions set by Regulatory Authorities in Markets outside of the United States and the European Union.

In Vitro Diagnostic means a product or service for in vitro testing of patient or subject specimens, or other biological materials, for use in the diagnosis or evaluation of a disease, medical condition or state of health, including to identify any genomic alterations or signatures, or for the prediction or monitoring of a response to any Therapeutic Product (or other treatment) or other prognostic use, whether used for research, exploratory purposes, or as a clinical diagnostic. For clarity, the term IVD includes IUOs, RUOs, Companion Diagnostics, Complementary Diagnostics and other IVDs.

In Vitro Diagnostic means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, which requires Regulatory Approval prior to commercial use, excluding approval required under the Clinical Laboratory Improvement Amendments (“CLIA”). This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.

Examples of In Vitro Diagnostic in a sentence

• This list has been incorporated by the JRC in its COVID-19 In Vitro Diagnostic Devices and Test Methods Database.The common list of rapid antigen tests is regularly being reviewed by Member States, and, if necessary, be updated in line with new results from independent validation studies becoming available and new tests entering the markets.

• In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends.

• Evaluation of 2 Real-Time PCR Assays for In Vitro Diagnostic Use in the Rapid and Multiplex Detection of EGFR Gene Mutations in NSCLC.

• For In Vitro Diagnostic Use.2. Normal precautions exercised in handling laboratory reagents should be followed.

• Represents costs incurred to develop processes and systems to establish initial compliance with the European Union Medical Device Regulation and the European Union In Vitro Diagnostic Medical Device Regulation, which represent a significant, unusual change to the existing regulatory framework.

• Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens.

• Moreover, the antigen tests included in the list should meet the three performance criteria as outlined in section I of this document.This list should be shared with ECDC and the Commission to prevent duplication of work and to feed into ongoing initiatives, particularly the “COVID-19 In Vitro Diagnostic Devices and Test Methods Database6, hosted by the Joint Research Centre (JRC).

• Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).

• Once the Health Security Committee has agreed with the update, it will be published on the Commission’s website and the COVID-19 In Vitro Diagnostic Devices and Test Methods Database will be updated accordingly.In parallel to the latest update of the EU common list, the Health Security Committee also agrees with the publication of an updated addendum.

• Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.

More Definitions of In Vitro Diagnostic

In Vitro Diagnostic means those reagents, instruments and systems intended for use in the diagnosis of disease or other conditions, including the state of health, in order to cure, mitigate, treat, or prevent or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

In Vitro Diagnostic. Means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimen derived from the human or animal; solely or principally to provide information for diagnostic, monitoring or compatibility purposes which includes but not limited to – reagents used for IVD purposes, calibrators, control chemicals, specimen receptacles, software and related instruments or apparatus or other articles and are used for the following test purposes; diagnosis; aid to diagnosis; screening; monitoring; predisposition; prognosis; prediction; determination of physiological status.

In Vitro Diagnostic means a product or service for in vitro testing of patient or subject specimens, or other biological materials, for use in the diagnosis or evaluation of a disease, including to identify any genomic alterations or signatures, or for the prediction or monitoring of a response to any product (or other agent) or other prognostic use, whether used for research, exploratory purposes or as a clinical diagnostic. For clarity, IVDs or In Vitro Diagnostics include “Investigation Use Only” products, “Research Use Only” products, companion diagnostics and complementary diagnostics.