ISO 15189:2003 Medical Laboratories
ISO 15189 :2003 Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation...
ISO 15189 :2003 Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation...
ISO 17025:2005
ISO/IEC 17025 General requirements for the compentence of testing and calibration laboratories specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing...
ISO/IEC 17025 General requirements for the compentence of testing and calibration laboratories specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing...
In Vitro Diagnostic
A reagent, instrument or system 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,...
A reagent, instrument or system 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,...
In Vitro Diagnostic Directive
The In Vitro Diagnostic Directive refers to Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices which defines the regulatory scheme for CE...
The In Vitro Diagnostic Directive refers to Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices which defines the regulatory scheme for CE...
In Vitro Diagnostic Multivariate Index Assay
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...
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...
Inclusion criteria
Conditions of clinical patients or clinical samples that cause them to be included in the clinical trials....
Conditions of clinical patients or clinical samples that cause them to be included in the clinical trials....
Indirect Harm
According to the European Union's regulatory scheme for in vitro diagnostic devices indirect harm is harm caused to a patient as the result of an incorrect result. Examples include misdiagnosis,...
According to the European Union's regulatory scheme for in vitro diagnostic devices indirect harm is harm caused to a patient as the result of an incorrect result. Examples include misdiagnosis,...
Institutional Review Board
Institutional Review Board (IRB) means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical...
Institutional Review Board (IRB) means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical...
Intended Use
A statement includes a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population...
A statement includes a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population...
Intended use population
Those subjects/patients (and specimen types) for whom the test is intended to be used; this is called the target population in STARD....
Those subjects/patients (and specimen types) for whom the test is intended to be used; this is called the target population in STARD....
Intercept
This term is relative to comparing 2 devices showing substantial equivalence. The y-intercept is the value of "y" in the equation y=mx+b when x=0. Ideally, if the devices perform identically,...
This term is relative to comparing 2 devices showing substantial equivalence. The y-intercept is the value of "y" in the equation y=mx+b when x=0. Ideally, if the devices perform identically,...
Interference
Something, other than the analyte, that causes the apparent concentration or intesity of the reagent or signal to increase....
Something, other than the analyte, that causes the apparent concentration or intesity of the reagent or signal to increase....
Internal quality control
Procedures run in association with the measurement of patients' specimens to evaluate whether the assay is capable of performing according to the lable within predefined tolerance limits....
Procedures run in association with the measurement of patients' specimens to evaluate whether the assay is capable of performing according to the lable within predefined tolerance limits....
International Organization for Standardization
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 130 countries, one from each country. ISO is a non-governmental organization established in 1947....
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 130 countries, one from each country. ISO is a non-governmental organization established in 1947....
Investigational Device Exemption
An IDE must be submitted for devices that are considered significant risk prior to beginning clinical trials....
An IDE must be submitted for devices that are considered significant risk prior to beginning clinical trials....
Investigational New Drug
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want...
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want...
Investigational Use Only
Products that have not been approved for marketing but are under investigation in a clinical trial are often referred to in the industry as "IUO" devices. Investigational devices (or their...
Products that have not been approved for marketing but are under investigation in a clinical trial are often referred to in the industry as "IUO" devices. Investigational devices (or their...
Labeling
For regulated products, labeling includes all information included on and with the device....
For regulated products, labeling includes all information included on and with the device....
Laboratory Developed Test
LDTs are tests that are developed by a single clinical laboratory for use only in that laboratory....
LDTs are tests that are developed by a single clinical laboratory for use only in that laboratory....
Limit of blank
Blank determinations plus 2-3 standard deviations....
Blank determinations plus 2-3 standard deviations....
Limit of detection
The lowest amount of analyte which can be detected within acceptable precision and accuracty, e.g. lowest limit detected greater than or equal to 95% of the time....
The lowest amount of analyte which can be detected within acceptable precision and accuracty, e.g. lowest limit detected greater than or equal to 95% of the time....
Linearity
The ability of the assay, within a given range, to provide results that are directly proportional to the concentration of the analyte in the test sample. This is determined with...
The ability of the assay, within a given range, to provide results that are directly proportional to the concentration of the analyte in the test sample. This is determined with...
Lot release criteria
The criteria met before a new batch of consumable device components can be marketed after being manufactured, e.g., reagents, test strips....
The criteria met before a new batch of consumable device components can be marketed after being manufactured, e.g., reagents, test strips....