Recognized Consensus Standards: Medical Devices

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

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Eveline Arnold   FDA/OC/CDER/OND/   240-402-5334   eveline.arnold@fda.hhs.gov

Tamara Pinkney   FDA/OC/CDRH/OPEQ/OIDRH/DPOM/   301-796-6182   tamara.pinkney@fda.hhs.gov

Standards Development Organization

CLSI Clinical Laboratory Standards Institute https://clsi.org/

FDA Specialty Task Group (STG)

InVitro Diagnostics

*These are provided as examples and others may be applicable.