Efficacy
The ability of a medical device to achieve the expected result in attaining diagnosis or treatment in an ideal setting....
The ability of a medical device to achieve the expected result in attaining diagnosis or treatment in an ideal setting....
Endogeneous interference
An interferent typical or inherent in the sample such as bilirubin, triglycerides, cholesterol, uric acid, rheumatoid factor, hematocrit, albumin, gamma globulin, HAMA or dehydration....
An interferent typical or inherent in the sample such as bilirubin, triglycerides, cholesterol, uric acid, rheumatoid factor, hematocrit, albumin, gamma globulin, HAMA or dehydration....
Equivocal zone
The range surrounding the cut-off where a sample has an equal probability of being positive or negative....
The range surrounding the cut-off where a sample has an equal probability of being positive or negative....
Exlusion criteria
Conditions of clinical patients or clinical samples that cause them to be excluded form clinical trials....
Conditions of clinical patients or clinical samples that cause them to be excluded form clinical trials....
External interference
Any interferent whether added to the body altering the sample (e.g. alcohol, medications, or citric acid), or some cross-reacting metabolites, or a biproduct of sample processing such as an anticoagulant...
Any interferent whether added to the body altering the sample (e.g. alcohol, medications, or citric acid), or some cross-reacting metabolites, or a biproduct of sample processing such as an anticoagulant...
External validity
The degree to which results from the study are sufficiently reflective of the “real world” performance of the device in the intended use population....
The degree to which results from the study are sufficiently reflective of the “real world” performance of the device in the intended use population....
False negative result
A negative test result for a subject in whom the condition of interest is present (as determined by the designated reference standard)....
A negative test result for a subject in whom the condition of interest is present (as determined by the designated reference standard)....
False positive result
A positive test result for a subject in whom the condition of interest is absent (as determined by the designated reference standard)....
A positive test result for a subject in whom the condition of interest is absent (as determined by the designated reference standard)....
Finished Device
Any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized....
Any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized....
Food and Drug Administration
The FDA is a part of the Department of Health and Human Services. It is FDA’s job to protect the public health by ensuring the safety of food products and...
The FDA is a part of the Department of Health and Human Services. It is FDA’s job to protect the public health by ensuring the safety of food products and...
Food, Drug and Cosmetic Act
The original Food and Drug act was enacted by congress in 1906. The current FD&C act was a complete rewrite of the first act and was passed into law by...
The original Food and Drug act was enacted by congress in 1906. The current FD&C act was a complete rewrite of the first act and was passed into law by...
Functional sensitivity
This is the lowest level the device can measure plus 2 standard deviations. This is determined by the lowest analyte concentration where %CV is acceptable, typically when the CVC is...
This is the lowest level the device can measure plus 2 standard deviations. This is determined by the lowest analyte concentration where %CV is acceptable, typically when the CVC is...
General Controls
General controls state that a device must not be adulterated or misbranded. In addition, a manufacturer of any medical device must be registered with FDA and maintain a tracking/complaint file...
General controls state that a device must not be adulterated or misbranded. In addition, a manufacturer of any medical device must be registered with FDA and maintain a tracking/complaint file...
Gold standard
A term applied to assays or standards that give a result as close to truth as possible. For example, culturing an etiologic agent from an aseptically obtained blood sample is...
A term applied to assays or standards that give a result as close to truth as possible. For example, culturing an etiologic agent from an aseptically obtained blood sample is...
Good Clinical Practices
The requirements for protection of human subjects and procedures for Institutional Review Boards are outlined in 21 CFR § 50 and 56....
The requirements for protection of human subjects and procedures for Institutional Review Boards are outlined in 21 CFR § 50 and 56....
Good Laboratory Practices
Good Laboratory Practices (GLP) for non-clinical laboratory studies are outlined in 21 CFR § 58...
Good Laboratory Practices (GLP) for non-clinical laboratory studies are outlined in 21 CFR § 58...
Hook effect
This effect occurs when the analyte concentration is so high in the sample that the reaction is saturated and the test result reads negative. Assays are evaluated to determine if...
This effect occurs when the analyte concentration is so high in the sample that the reaction is saturated and the test result reads negative. Assays are evaluated to determine if...
Hypothesis testing
The testing of 2 or more statistical hypotheses that is mutually exclusive so that exactly one hypothesis can be accepted at a specified confidence interval....
The testing of 2 or more statistical hypotheses that is mutually exclusive so that exactly one hypothesis can be accepted at a specified confidence interval....