510(k)
A 510(k) is another name for a Premarket Notification application. 510(k) applications are required for some Class I devices and all Class II devices....
A 510(k) is another name for a Premarket Notification application. 510(k) applications are required for some Class I devices and all Class II devices....
American Association of Blood Banks
Established in 1947, the American Association of Blood Banks is an international association of blood banks, including hospital and community blood centers, transfusion and transplantation services and individuals involved in...
Established in 1947, the American Association of Blood Banks is an international association of blood banks, including hospital and community blood centers, transfusion and transplantation services and individuals involved in...
American Medical Association
The AMA is an organization of physicians that considers themselves a patient advocacy group. They are also involved in developing insurance reimbursement codes....
The AMA is an organization of physicians that considers themselves a patient advocacy group. They are also involved in developing insurance reimbursement codes....
American National Standards Institute
ANSI is a private, non-profit organization (501(c)3) that administers and coordinates the U.S. voluntary standardization and conformity assessment system. The Institute's mission is to enhance both the global competitiveness of...
ANSI is a private, non-profit organization (501(c)3) that administers and coordinates the U.S. voluntary standardization and conformity assessment system. The Institute's mission is to enhance both the global competitiveness of...
American Society for Quality
ASQ is a society of individual and organizational members dedicated to the ongoing, development, advancement, and promotion of quality concepts, principles, and techniques. ASQ has a library of standards and...
ASQ is a society of individual and organizational members dedicated to the ongoing, development, advancement, and promotion of quality concepts, principles, and techniques. ASQ has a library of standards and...
American Society for Testing and Materials
ASTM strives to be the foremost developer and provider of voluntary consensus standards, related technical information, and services having internationally recognized quality and applicability that promote public health and safety,...
ASTM strives to be the foremost developer and provider of voluntary consensus standards, related technical information, and services having internationally recognized quality and applicability that promote public health and safety,...
Analyte Specific Reagents
ASRs are reagents composed of chemicals or antibodies that may be thought of as the "active ingredients" of tests that are used to identify one specific disease or condition....
ASRs are reagents composed of chemicals or antibodies that may be thought of as the "active ingredients" of tests that are used to identify one specific disease or condition....
Analytical Sensitivity
The analyte concentration at which 95% of the test results are positive. This is determined by performing multiple runs of the zero calibrator. It can be determined by the intercept...
The analyte concentration at which 95% of the test results are positive. This is determined by performing multiple runs of the zero calibrator. It can be determined by the intercept...
Analytical Specificity
For quantitative tests, the ability of an analytical method to determine only the component it purports to measure or the extent to which the assay responds only to all subsets...
For quantitative tests, the ability of an analytical method to determine only the component it purports to measure or the extent to which the assay responds only to all subsets...
Association of Medical Device Manufacturers
AMDM is a nonprofit trade association that provides information and educatiion to IVD manufaturers....
AMDM is a nonprofit trade association that provides information and educatiion to IVD manufaturers....
Batch
One or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that...
One or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that...
Bias
The systematic deviation of test results from the accepted reference value....
The systematic deviation of test results from the accepted reference value....
CLIA - Waived Test
Simple laboratory tests which-- (1) Are cleared by FDA for home use; (2) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible;...
Simple laboratory tests which-- (1) Are cleared by FDA for home use; (2) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible;...
Calibration
The process of testing and adjusting an instrument, kit or test system to provide a known relationship between the measurement response and the value of the substance being measured by...
The process of testing and adjusting an instrument, kit or test system to provide a known relationship between the measurement response and the value of the substance being measured by...
Calibrator
Calibrators are materials whose concentrations are known and to which the test sample is compared in order to determine the concentration of the substance being measured. Calibrators are used to...
Calibrators are materials whose concentrations are known and to which the test sample is compared in order to determine the concentration of the substance being measured. Calibrators are used to...
Center for Biologics Evaluation and Research
CBER is the Center within the FDA responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics. CBER reviews some in vitro diagnostic...
CBER is the Center within the FDA responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics. CBER reviews some in vitro diagnostic...
Center for Devices and Radiological Health
CDRH is the Center within the FDA responsible for protecting the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human...
CDRH is the Center within the FDA responsible for protecting the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human...
Center for Drug Evaluation and Research
CDER is the Center with FDA responsible for protecting the public health by providing reasonable assurance of the safety and effectiveness of drugs....
CDER is the Center with FDA responsible for protecting the public health by providing reasonable assurance of the safety and effectiveness of drugs....
Centers for Medicare and Medicaid Services
CMS is the federal agency that administers Medicare, Medicaid and the State Children’s Health Insurance Program (SCHIP). Formerly known as the Health Care Financing Administration (HCFA)....
CMS is the federal agency that administers Medicare, Medicaid and the State Children’s Health Insurance Program (SCHIP). Formerly known as the Health Care Financing Administration (HCFA)....
Certificate for Non-clinical Research Use Only
An export certificate provided by FDA to manufacturers for the export of a non-clinical research use only product, material, or component that is not intended for human use which may...
An export certificate provided by FDA to manufacturers for the export of a non-clinical research use only product, material, or component that is not intended for human use which may...
Certificate of Exportability
An export certificate provided to manufacturers for the export of products not approved for marketing in the United States (unapproved products) that meet the requirements of Sections 801(e) or 802...
An export certificate provided to manufacturers for the export of products not approved for marketing in the United States (unapproved products) that meet the requirements of Sections 801(e) or 802...
Certificate of a Pharmaceutical Product
Certificate of a Pharmaceutical Product conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when the product in question...
Certificate of a Pharmaceutical Product conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when the product in question...
Certificate to Foreign Government
An export certificate provided to manufacturers by the FDA for the export of products legally marketed in the United States....
An export certificate provided to manufacturers by the FDA for the export of products legally marketed in the United States....
Chemistry, Manufacturing & Controls
Chemistry, manufacturing & controls refers to a specific collection of information that must be supplied to FDA in preparation for a drug-related application submitted in the Common Technical Document (CTD)...
Chemistry, manufacturing & controls refers to a specific collection of information that must be supplied to FDA in preparation for a drug-related application submitted in the Common Technical Document (CTD)...
Class I Device
A device that requires only general controls....
A device that requires only general controls....
Class II Device
A device is designated Class II when general controls are insufficient to ensure that the it will be safe and effective. Class II devices are subject to special controls including...
A device is designated Class II when general controls are insufficient to ensure that the it will be safe and effective. Class II devices are subject to special controls including...
Class III Device
A device is designated Class III that is not Class I or Class II because insufficient information exists to know whether either general controls or special controls are adequate to...
A device is designated Class III that is not Class I or Class II because insufficient information exists to know whether either general controls or special controls are adequate to...
Clinical Hold
FDA has the regulatory authority to place a clinical trial on clinical hold if there is insufficient information provided in the Investigational Device Exemption (IDE) of Investigational New Drug (IND)...
FDA has the regulatory authority to place a clinical trial on clinical hold if there is insufficient information provided in the Investigational Device Exemption (IDE) of Investigational New Drug (IND)...
Clinical Laboratory Improvement Act
The Clinical Laboratory Improvement Act of 1988 put into place requirements that laboratories need to meet to perform various types of testing. These include certification and inspection....
The Clinical Laboratory Improvement Act of 1988 put into place requirements that laboratories need to meet to perform various types of testing. These include certification and inspection....
Clinical Research Associate
A CRA is responsible for the day-to-day management of a clinical trial site or sites. Clinical research associates typically have experience with the products being studied and is responsible for...
A CRA is responsible for the day-to-day management of a clinical trial site or sites. Clinical research associates typically have experience with the products being studied and is responsible for...
Clinical Research Organization
A CRO is an organization that performs clinical trials on contract for manufacturers of research products....
A CRO is an organization that performs clinical trials on contract for manufacturers of research products....
Clinical Utility
The device is effective for its intended use and will provide clinically significant results in a large portion of the target population....
The device is effective for its intended use and will provide clinically significant results in a large portion of the target population....
Clinical and Laboratory Standards Institute
CLSI is a globally recognized, voluntary consensus standards-developing organization that enhances the value of medical testing within the healthcare community through the development and dissemination of standards, guidelines, and best...
CLSI is a globally recognized, voluntary consensus standards-developing organization that enhances the value of medical testing within the healthcare community through the development and dissemination of standards, guidelines, and best...
Code of Federal Regulations
The CFR is the compilation of Federal regulations. 21 CFR contains the regulations that pertain to food, drugs, device, biologics and cosmetics....
The CFR is the compilation of Federal regulations. 21 CFR contains the regulations that pertain to food, drugs, device, biologics and cosmetics....
College of American Pathologists
The College of American Pathologists (CAP) is a medical society serving more than 15,000 physician members and the laboratory community throughout the world. It is the world's largest association composed...
The College of American Pathologists (CAP) is a medical society serving more than 15,000 physician members and the laboratory community throughout the world. It is the world's largest association composed...
Complaint
Any written, electronic, or oral communication that alleges deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution...
Any written, electronic, or oral communication that alleges deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution...
Component
Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device....
Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device....
Contraindication
A piece of the label which identifies situations where the device should not be used because the risk of use outweighs any possible benefit. This includes known hazards....
A piece of the label which identifies situations where the device should not be used because the risk of use outweighs any possible benefit. This includes known hazards....
Correlation
A measure of the degree of linear relationship between two variables. Correlation (r) varies from -1.00 to +1.00. Negative correlation means that as one variable decreases, the other increases. Positive...
A measure of the degree of linear relationship between two variables. Correlation (r) varies from -1.00 to +1.00. Negative correlation means that as one variable decreases, the other increases. Positive...
Cross-reactivity
Shared or similar antigenic response to the analyte which falsely elevates the signal measuring the analyte....
Shared or similar antigenic response to the analyte which falsely elevates the signal measuring the analyte....
Cut-off
A test value that marks the upper or lower boundary between a negative and a positive interpretation of the test result when the test is qualitative. Theoretically, when testing a...
A test value that marks the upper or lower boundary between a negative and a positive interpretation of the test result when the test is qualitative. Theoretically, when testing a...
Department of Health and Human Services
HHS is the cabinet-level department that contains FDA CMS, CDC and many other agencies....
HHS is the cabinet-level department that contains FDA CMS, CDC and many other agencies....
Design Control
This is a general term for a system which includes documented design input and output requirements, design review and a design history file....
This is a general term for a system which includes documented design input and output requirements, design review and a design history file....
Design History File
A compilation of records which describes the design history of a finished device....
A compilation of records which describes the design history of a finished device....
Design Output
The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master...
The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master...
Design Review
A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify...
A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify...
Design Validation
Establishing by objective evidence that device specifications conform to user needs and intended use(s)....
Establishing by objective evidence that device specifications conform to user needs and intended use(s)....
Device History Record
A compilation of records containing the production history of a finished device -- the records that document what actually happened during manufacturing....
A compilation of records containing the production history of a finished device -- the records that document what actually happened during manufacturing....
Device Master Record
These are the documents that give those doing manufacturing and quality control testing instructions on what to do. They contain procedures and specifications for a finished device....
These are the documents that give those doing manufacturing and quality control testing instructions on what to do. They contain procedures and specifications for a finished device....
Diagnostic accuracy
The extent of agreement between the outcome of the new test and the reference standard....
The extent of agreement between the outcome of the new test and the reference standard....
Discrepant resolution
A two-stage testing process that uses a resolver to attempt to classify patients for whom the new test and non-reference standard disagree....
A two-stage testing process that uses a resolver to attempt to classify patients for whom the new test and non-reference standard disagree....
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....
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....
Malfunction
The failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device....
The failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device....
Management with Executive Responsibility
Those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system.2...
Those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system.2...
Manufacturer
Any person who designs, manufacturers, fabricates, assembles, or processes a finished device. Manufacturer includes but it not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing,...
Any person who designs, manufacturers, fabricates, assembles, or processes a finished device. Manufacturer includes but it not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing,...
Manufacturing Material
Any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or...
Any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or...
Matrix
The type of sample, e.g. saliva, urine, spinal fluid, tears, blood, plasma, serum, hair....
The type of sample, e.g. saliva, urine, spinal fluid, tears, blood, plasma, serum, hair....
Matrix effect
The impact of changing a matrix on the perfomance of the assay compared to the matrix used when the assay was last cleared. This is evaluated by a matrix comparison...
The impact of changing a matrix on the perfomance of the assay compared to the matrix used when the assay was last cleared. This is evaluated by a matrix comparison...
Medical Device Reportable Event
An event that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or an event about which manufacturers have received or...
An event that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or an event about which manufacturers have received or...
Medical Device Reporting
This is a requirement stated in 21 CFR Part 803 – Medical Device Reporting. Under this part, medical device user facilities and manufacturers must report deaths and serious injuries to...
This is a requirement stated in 21 CFR Part 803 – Medical Device Reporting. Under this part, medical device user facilities and manufacturers must report deaths and serious injuries to...
Medical decision point
The value above or below shich a physician will alter their medical therapy or interpretation of the disease or condition....
The value above or below shich a physician will alter their medical therapy or interpretation of the disease or condition....
Method comparison
A comparison of results where an assay and either a predicate assay or a reference method are compared over the range of the new assay. The mathematical equation describing the...
A comparison of results where an assay and either a predicate assay or a reference method are compared over the range of the new assay. The mathematical equation describing the...
Near patient testing
Testing performed outside a central laboratory, e.g., home use, workplace, emergency room, physician office....
Testing performed outside a central laboratory, e.g., home use, workplace, emergency room, physician office....
Negative percent agreement
The proportion of non-reference standard negative subjects in whom the new test is negative....
The proportion of non-reference standard negative subjects in whom the new test is negative....
Negative predictive value
The proportion of non-reference standard negative subjects in whom the new test is negative....
The proportion of non-reference standard negative subjects in whom the new test is negative....
New Drug Application
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the...
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the...
Nonconformity
The nonfulfillment of a specified requirement...
The nonfulfillment of a specified requirement...
Objective clinical endpoint
Clinical signs, symptoms, and other indicators that are well recognized in the standard practice of medicine to indicate the disease or condition for the intended use of the assay....
Clinical signs, symptoms, and other indicators that are well recognized in the standard practice of medicine to indicate the disease or condition for the intended use of the assay....
Office of In Vitro Diagnostic Devices
The office within CDRH responsible for regulating in vitro diagnostic products....
The office within CDRH responsible for regulating in vitro diagnostic products....
Over-the-Counter
Drugs and devices that may be sold directly to consumers without the need for a prescription....
Drugs and devices that may be sold directly to consumers without the need for a prescription....
Overall agreement
The proportion of subjects in whom the new test and the non-reference standard give the same outcome....
The proportion of subjects in whom the new test and the non-reference standard give the same outcome....
PMA Ammendment
A submission that reports a change to a PMA that has been submitted but not approved....
A submission that reports a change to a PMA that has been submitted but not approved....
PMA Supplement
A submission that reports a change to a Class III device that has an approved PMA. A PMA supplement must be submitted before making a change affecting the safety or...
A submission that reports a change to a Class III device that has an approved PMA. A PMA supplement must be submitted before making a change affecting the safety or...
Package insert
Informational material that accompanies the instruments, reagents, and other laboratory products that gives the instructions for use of the device; contains precautions, warnings and limitations....
Informational material that accompanies the instruments, reagents, and other laboratory products that gives the instructions for use of the device; contains precautions, warnings and limitations....
Performance characteristic
A property of a test that is used to describe its quality e.g. accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range....
A property of a test that is used to describe its quality e.g. accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range....
Positive percent agreement
The proportion of non-reference standard positive subjects in whom the new test is positive....
The proportion of non-reference standard positive subjects in whom the new test is positive....
Positive predictive value
The likelihood that an individual with a positive test result has a particular disease or other condition, that the test is designed to detect....
The likelihood that an individual with a positive test result has a particular disease or other condition, that the test is designed to detect....
Postmarket surveillance
The active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. means the active, systematic, scientifically valid collection, analysis, and interpretation of data...
The active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. means the active, systematic, scientifically valid collection, analysis, and interpretation of data...
Precision
The closeness in agreement between independent test results obtained under stipulated conditions. It is typically reported as standard deviations or coefficient of variation which describes imprecision....
The closeness in agreement between independent test results obtained under stipulated conditions. It is typically reported as standard deviations or coefficient of variation which describes imprecision....
Predicate Device
A device that has been FDA cleared via a 510(k) that is used as an compator product....
A device that has been FDA cleared via a 510(k) that is used as an compator product....
Premarket Approval Application
A PMA is a submission that is required for Class III medical devices. The requirements for the contents of a PMA are presented in 21 CFR § 814.20....
A PMA is a submission that is required for Class III medical devices. The requirements for the contents of a PMA are presented in 21 CFR § 814.20....
Presciption home use
Prescription home use in-vitro diagnostic devices are intended to detect and/or measure analytes e.g. antigens, antibodies, hormones etc. in clinical specimens. They are essentially the same as other clinical lab...
Prescription home use in-vitro diagnostic devices are intended to detect and/or measure analytes e.g. antigens, antibodies, hormones etc. in clinical specimens. They are essentially the same as other clinical lab...
Prevalence
The frequency of a condition of interest at a given point in time expressed as a fraction of the number of individuals in a specified group with the condition of...
The frequency of a condition of interest at a given point in time expressed as a fraction of the number of individuals in a specified group with the condition of...
Principal Investigator
An individual who actually conducts the investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of...
An individual who actually conducts the investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of...
Process Validation
Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications....
Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications....
Product
Components, manufacturing materials, in-process devices, finished devices, and returned devices....
Components, manufacturing materials, in-process devices, finished devices, and returned devices....
Prospective samples
Samples are obtained directly from patients enrolled in a study whose purpose is to investigate the performance of the device....
Samples are obtained directly from patients enrolled in a study whose purpose is to investigate the performance of the device....
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....
Validation
Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. Please see also: verification....
Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. Please see also: verification....
Verification
Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Please see also: validation....
Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Please see also: validation....
Warnings
Information to make users aware of potential serious adverse events or safety hazards that may occur if device is used improperly....
Information to make users aware of potential serious adverse events or safety hazards that may occur if device is used improperly....
de novo 510(k)
A type of 510(k) used when FDA agrees that the risk of the product is appropriate for Class II but there is not a predicate device. This mechanism may only...
A type of 510(k) used when FDA agrees that the risk of the product is appropriate for Class II but there is not a predicate device. This mechanism may only...