Compliance Statements

Policy

ARUP abides by regulations pertaining to the appropriate language for labeling non-FDA approved test methods offered by ARUP.

Purpose

The U.S. Food and Drug Administration (FDA) considers many clinical laboratory tests as Class I and II medical devices and as such reviews and approves tests and methodologies for “In Vitro Diagnostic Use.” Clinical diagnostic tests without FDA approval must meet the performance specifications according to the Clinical Laboratory Improvement Amendment of 1988 (CLIA).

Compliance Statement A

For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay

Analyte Specific Reagent. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, the FDA has determined that such clearance or approval is not necessary.

Compliance Statement B

For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations

This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Compliance Statement C

For human genetic inheritable conditions and mutations

This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online.

Compliance Statement D

For laboratory tests using a manufactured RUO kit

This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.