IVD Glossary Terms (A-G)

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	IVD Glossary Terms (A-G)
Search Our Site	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.... 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... 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.... 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... 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... 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,... 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.... 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... 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... Association of Medical Device Manufacturers 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... Bias The systematic deviation of test results from the accepted reference value.... 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... 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... 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... 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... 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.... 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).... 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... 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 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... Certificate to Foreign Government 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)... Class I Device 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... 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... 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;... 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... 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)... 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.... 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... Clinical Research Organization 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.... 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.... 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... 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... 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.... 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.... 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... Cross-reactivity 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... 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... Department of Health and Human Services 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.... Design History File 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... 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... Design Validation 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.... 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.... Diagnostic accuracy 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.... Efficacy 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.... Equivocal zone 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.... 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... 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.... 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).... 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).... 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.... 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... 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... 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... 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... 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... Good Clinical Practices 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...	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