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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 7-306
Standard
CLSI  EP06 2nd Edition
Evaluation of the Linearity of Quantitative Measurement Procedures
Scope/Abstract
This guideline provides recommendations for designing, analyzing, and interpreting linearity studies for quantitative measurement procedures. This guideline is intended for manufacturers and developers seeking to validate the linearity of a measurement procedure throughout a stated concentration interval, especially
the interval that includes the measurement procedure's lower limit of quantitation (LLoQ) and upper limit of quantitation (ULoQ). It is also intended for laboratorians who verify the linearity of a measurement procedure and for regulatory agencies responsible for overseeing in vitro diagnostic (IVD) manufacturers or end-user laboratories.

This guideline does not include information on linearity issues encountered during the measurement procedure development phase, such as efficiently identifying the widest possible interval for a linearity claim or selecting calibration points, although the experimental design and data analysis principles described herein can be of value
during that phase.

Before the laboratory begins formal linearity verification studies, the measurement procedure's intended analytical measuring interval claim should already have been determined based on the results of linearity, precision, and other studies that have been evaluated using a clinically informed error budget for imprecision,
bias, etc.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR 58 Good Laboratory Practice for Non Clinical Studies
21 CFR 820 Quality Systems Regulations
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
 Yung Chan
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/
  301-796-6138
  yung.chan@fda.hhs.gov
 Marina V. Kondratovich
  FDA/CDRH/OPEQ/OIDRH/
  301-796-6036
  marina.kondratovich@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.
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