Laboratory Developed Test definition

Laboratory Developed Test means an in vitro diagnostic test that is designed, validated, and performed within a single laboratory and otherwise complies with FDA’s guidance with respect to LDTs.

Laboratory Developed Test means any test, process or procedure used to test or assay any type of patient biological sample, the results of which would then normally be entered into the medical record of the patient providing such biological sample; provided, however, any test, process or procedure performed using an IVD Test Kit shall not be considered to be a Laboratory Developed Test.

Laboratory Developed Test or "LDT" means a laboratory developed test as defined by the FDA The FDA defines a laboratory developed test as an In Vitro Diagnostic Product that is manufactured by and used within a single laboratory (i.e. a laboratory with a single CLIA certificate). Laboratory Developed Tests are considered "devices," as defined by the FD&C Act, and are therefore subject to regulatory oversight by FDA, and are regulated by the CMC under CLIA. CLIA does not address the clinical validity of any LDT (clinical validity refers to the accuracy with which the LDT identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient).

Examples of Laboratory Developed Test in a sentence

• Test for COVID-19 with either a polymerase chain reaction (PCR) or antigen test has an Emergency Use Authorization (EUA) by the FDA or is operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.

• Any PCR (molecular) or antigen test used must either have Emergency Use Authorization by the U.S. Food and Drug Administration or be operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.

• Where a covered contractor requires an unvaccinated covered worker to submit proof of a COVID-19 test, the worker may choose either antigen or molecular tests that have EUA by the FDA or are operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.

• Beginning September 19, 2021, school personnel who are not fully vaccinated must be tested for COVID-19 with either a PCR or antigen test that either has emergency use authorization by the FDA or is operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services (CMS) until they are fully vaccinated.

• This Laboratory Developed Test utilises the RUO rabbit monoclonal antibody clone E1L3N (Cell Signalling Technologies) and Leica Bond III instrumentation.

More Definitions of Laboratory Developed Test

Laboratory Developed Test means an in vitro diagnostic test that is designed, manufactured and used within a single laboratory for which the FDA is not enforcing any premarket review or other Regulatory Approval requirements.

Laboratory Developed Test or “LDT” means a laboratory developed test as defined by the FDA. The FDA defines a laboratory developed test as an In Vitro Diagnostic Product that is manufactured by and used within a single laboratory (i.e. a laboratory with a single CLIA certificate). Laboratory Developed Tests are considered “devices,” as defined by the FD&C Act, and are therefore subject to regulatory oversight by FDA, and are regulated by the CMC under CLIA. CLIA does not address the clinical validity of any LDT (clinical validity refers to the accuracy with which the LDT identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient).

Laboratory Developed Test shall have the meaning ascribed to such term in Section 3.1(kk).

Laboratory Developed Test means a clinical diagnostic test for use in the diagnosis of disease or other conditions that was developed by a CLIA certified clinical laboratory for use in that laboratory.

Laboratory Developed Test means the provision of test results from use of a Licensed Product or Licensed Products to assay a patient urine or prostate biopsy sample, to be entered into the medical history record of the patient providing the urine or prostate biopsy sample.

Laboratory Developed Test. (“LDT”) shall mean any in vitro diagnostic test or device that may be legally marketed in a given territory without the need for pre-marketing approval from the regulatory agency responsible for that territory.

Laboratory Developed Test. (LDT) means an in vitro diagnostic test that is developed, validated and/or used only for that particular clinical laboratory’s in-house pathology purposes. As such, an LDT is not intended for use in or sale to other laboratories. If an LDT is made available for use in or sale to other laboratories, it would no longer be exempted from pre- market registration and prior approval will be required from the Health Sciences Authority.