badge-certificate

Licensure

View ARUP’s licensure, accreditations, certifications, and permits.

View the list

 
health-book

Public Reporting

ARUP is required to report certain test results to public health departments.

Learn more

 
badge-protect

Privacy & HIPAA

Learn about our adherence to HIPAA, GDPR, and our privacy policies.

View information

 

Purpose

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). ARUP includes a statement with the test result when this type of test has been performed.

Compliance Statement A

For laboratory developed tests using a manufacturer labeled Analyte Specific Reagent (ASR) as the reagent providing the specificity of the assay

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Statement B

For laboratory developed tests (LDT) and for FDA approved, cleared or 510(k) exempt assays with modifications

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Statement C

For human genetic inheritable conditions and mutations

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

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

Compliance Statement D

For laboratory tests using a manufactured Research Use Only (RUO) kit

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.