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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 7-224
Standard
CLSI EP28-A3c (Formerly C28-A3c)
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition
Scope/Abstract
This document offers a protocol for determining reference intervals that meet the minimum requirements for reliability and usefulness. The guideline focuses on health-associated reference values as they relate to quantitative clinical laboratory tests. Included are various requirements for studies to determine reference values for a new analyte or a new analytical method of a previously measured analyte. Also discussed is the transfer of established reference values from one laboratory to another.
Extent of Recognition
Complete standard
FDA Technical Contacts
 Tamara Pinkney
  FDA/OC/CDRH/OPEQ/OIDRH/DPOM/
  301-796-6182
  tamara.pinkney@fda.hhs.gov
 Zhiheng Xu
  FDA/OC/CDRH/OPEQ/OCEA/DCEAII/
  301-796-6094
  zhiheng.xu@fda.hhs.gov
 Eveline Arnold
  FDA/OC/CDER/OND/
  240-402-5334
  eveline.arnold@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
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