The U.S. Food and Drug Administration (FDA) reviews and approves tests for “In Vitro Diagnostic Use.” Clinical diagnostic tests that do not have FDA clearance or approval must meet validated performance specifications as required by Clinical Laboratory Improvement Amendment of 1988 (CLIA). Where appropriate, the following statement is appended to test results, “This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.”
To identify tests, ARUP uses the following categories:
For tests that use a standard method, which is universally applied across laboratories and has an established record of reliability and clinical validity.
For tests that use an in vitro diagnostic (IVD) that has been cleared or approved by the FDA.
For tests that use an FDA approved/cleared/exempt IVD that has been modified from the manufacturer’s instructions.
Analyte Specific Reagent (ASR)
For tests using a manufacturer labeled Analyte Specific Reagent (ASR) as the reagent providing the specificity of the assay (previously referred to as Compliance Statement A).
Laboratory Developed Test (LDT)
For tests developed and validated by ARUP (previously referred to as Compliance Statement B, C, or D)
Emergency Use Authorization (EUA)
For tests that use an IVD authorized by the FDA for Emergency Use.
Humanitarian Use Device (HUD)
For tests that use an IVD approved under an FDA Humanitarian Device Exemption.