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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 057 Date of Entry 12/20/2021 
FR Recognition Number 7-311
Standard
CLSI  EP39, 1st Edition
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
Scope/Abstract
This guideline establishes a definition of "surrogate sample" and an approach for selecting, preparing, and using these samples. It discusses surrogate sample:
- Composition
- Technical preparation
- Selection criteria
- Documentation and planning
- Use in specific performance study types
The intended users of this guideline are in vitro diagnostic (IVD) device developers, laboratorians, and regulators.
This guideline does not describe performance study design, which is covered in other standards and guidelines (see CLSI document EP19).
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)*
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 Contact
 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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