What are the test classifications?

Analytical tests offered by Mayo Clinic Laboratories are classified according to the FDA labeling of the test kit or reagents and their usage. Where appropriate, analytical test listings contain a statement regarding these classifications, test development, and performance characteristics. The classifications include:

• Standard Method - This test uses a standard method. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.
• FDA Approved, Cleared, or Exempt (IVD) - This test has been cleared or approved by the U.S. Food and Drug Administration (or is exempt from FDA review) and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
• FDA Modified - This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.
• Analyte Specific Reagent (ASR) - This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
• Laboratory Developed Test - This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

 

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