Qualitative assay
An assay that produces a positive or negative result....
An assay that produces a positive or negative result....
Quality
The totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance....
The totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance....
Quality Control
The expected reaction or concentration of analytes is within known limits to cause either positive or negative results when used in place of a human sample. They are materials that...
The expected reaction or concentration of analytes is within known limits to cause either positive or negative results when used in place of a human sample. They are materials that...
Quality Policy
The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility....
The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility....
Quality System
The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management....
The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management....
Quality System Regulation
The QSR defines Good Manufacturing Procedures (GMPs) for medical devices. The QSR defines the requirements that govern the methods used in, and the facilities and controls used for, the design,...
The QSR defines Good Manufacturing Procedures (GMPs) for medical devices. The QSR defines the requirements that govern the methods used in, and the facilities and controls used for, the design,...
Quality audit
A systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of...
A systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of...
Quantitative assay
An assay that produces a quantitative numeric result, sometimes it is required that a quantitative test is traceable to a standard....
An assay that produces a quantitative numeric result, sometimes it is required that a quantitative test is traceable to a standard....
Range
The smallest to the largest observed value. The total span of values a device can provide results....
The smallest to the largest observed value. The total span of values a device can provide results....
Real-time stability
Studies establish the expiration dating for the entire kit and its individual components under recommended storage conditions, and this information is provided on the label....
Studies establish the expiration dating for the entire kit and its individual components under recommended storage conditions, and this information is provided on the label....
Recall
The correction of removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death....
The correction of removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death....
Recovery
The increase in analyte concentration or activity after adding a known amount of the analyte to a sample....
The increase in analyte concentration or activity after adding a known amount of the analyte to a sample....
Reference method
A thoroughly investigated method, in which exact and clear descriptions of the necessary conditions and procedures are given for the accurate determination of one or more property values, and in...
A thoroughly investigated method, in which exact and clear descriptions of the necessary conditions and procedures are given for the accurate determination of one or more property values, and in...
Reference range
The range of test values expected for a designated population of individuals. Demographic information is submitted when data is presented....
The range of test values expected for a designated population of individuals. Demographic information is submitted when data is presented....
Reference standard
The best available method for establishing the presence or absence of the target condition; the reference standard can be a single test or method, or a combination of methods and...
The best available method for establishing the presence or absence of the target condition; the reference standard can be a single test or method, or a combination of methods and...
Remanufacturer
Any person who process, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use....
Any person who process, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use....
Remedial Action
Any action, other than routine maintenance or servicing of a device, necessary to prevent recurrence of a reportable event....
Any action, other than routine maintenance or servicing of a device, necessary to prevent recurrence of a reportable event....
Repeatability
The closeness of agreement between the results of successive measurements of the same samples carried out under the same conditions of measurement e.g. within run precision....
The closeness of agreement between the results of successive measurements of the same samples carried out under the same conditions of measurement e.g. within run precision....
Reportable range
The range of test values over which the device response is valid. Data for linearity, dilution testing, parallelism, or spiked recovery may be used to support the reportable range....
The range of test values over which the device response is valid. Data for linearity, dilution testing, parallelism, or spiked recovery may be used to support the reportable range....
Reproducibility
The closeness in agreement of repeated testing where the test conditions are changed. Changes most often involve time e.g. between run precision....
The closeness in agreement of repeated testing where the test conditions are changed. Changes most often involve time e.g. between run precision....
Research Use Only
In vitro diagnostic products that are in a research phase must not be represented as investigational or cleared devices. As a result they must bear the statement, prominently placed; “For...
In vitro diagnostic products that are in a research phase must not be represented as investigational or cleared devices. As a result they must bear the statement, prominently placed; “For...
Retrospective samples
Samples that were banked or stored materials obtained from patients. The samples were usually obtained for general purposes unrelated to the evaluation of a new assay....
Samples that were banked or stored materials obtained from patients. The samples were usually obtained for general purposes unrelated to the evaluation of a new assay....
Rework
Action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution....
Action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution....
Semiquantitative assay
The assay produces a positive or negative result and provides information such that the positive result can be associated with a numeric result thereby providing categories or levels for qualitative...
The assay produces a positive or negative result and provides information such that the positive result can be associated with a numeric result thereby providing categories or levels for qualitative...
Sensitivity
The proportion of subjects with the target condition in whom the test is positive; calculated as 100xTP/(TP+FN). FN is the number of subjects/specimens with false negative test results. TP is...
The proportion of subjects with the target condition in whom the test is positive; calculated as 100xTP/(TP+FN). FN is the number of subjects/specimens with false negative test results. TP is...
Significant risk
A significant risk device means an investigational device that: Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;...
A significant risk device means an investigational device that: Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;...
Specificity
The proportion of subjects without the target condition in whom the test is negative; calculated as 100xTN/(FP+TN). TN is the number of subjects/specimens with true negative test results. FP is...
The proportion of subjects without the target condition in whom the test is negative; calculated as 100xTN/(FP+TN). TN is the number of subjects/specimens with true negative test results. FP is...
Stability
The duration a diagnostic device or its components maintain their integrity such that they can perform according to their labeling. Real time, accelerated and stress evaluations are performed to determine...
The duration a diagnostic device or its components maintain their integrity such that they can perform according to their labeling. Real time, accelerated and stress evaluations are performed to determine...
Standards for Reporting of Diagnostic Accuracy Initiative
The STARD Initiative pertains to studies of diagnostic accuracy....
The STARD Initiative pertains to studies of diagnostic accuracy....
Statistically significant
The decision to reject a null hypothesis based on the comparison of the probability of observing the data if the null hypothesis is true (p-value) and the probability that a...
The decision to reject a null hypothesis based on the comparison of the probability of observing the data if the null hypothesis is true (p-value) and the probability that a...
Substantial Equivalence
For Class I and Class II products manufacturers must show the new device is very similar in design and performance with a product already FDA cleared or approved. When FDA...
For Class I and Class II products manufacturers must show the new device is very similar in design and performance with a product already FDA cleared or approved. When FDA...
Traceable
The connection between reference material and calibrators or controls....
The connection between reference material and calibrators or controls....