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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 065 Date of Entry 12/22/2025 
FR Recognition Number 7-351
Standard
CLSI  EP46 1st Edition
Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures
Scope/Abstract
CLSI EP46 provides guidance for selecting the relevant sources for establishing allowable total error (ATE) goals and/or limits for quantitative medical laboratory measurement procedures. This guidance is suitable for both commercial products as well as laboratory-developed tests (LDTs). It is particularly useful for end-user medical laboratories to set acceptance criteria (ie, limits) for total analytical error (TAE) before performing studies described in CLSI EP21 and can be used to determine acceptability of a measurement procedure for use to inform clinical decisions.

The intended users of CLSI EP46 are developers of measurement procedures (both commercial manufacturers and laboratories that create LDTs), regulatory authorities, and medical laboratory personnel.

Users should learn how to:
- Describe error and classifications of error as preanalytical, analytical, or postanalytical; random or systematic.
- Compare frameworks for applying total error concepts.
- Consider the multiple sources of error contributing to bias and imprecision in a measurement procedure.
- Determine ATE limits using models based on clinical outcome studies, biological variation of the measurand, and/or the state of the art of the measurand, dependent on the availability of data.

CLSI EP46 is not intended to provide recommendations or endorsement for specific sources of ATE limits. It does not provide guidance on estimating and evaluating TAE for quantitative measurement procedures, but instead directs users to CLSI EP21 for information on this topic.
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 820 Quality Systems Regulations
21 CFR 58 Good Laboratory Practice for Non-Clinical Studies
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
 Marina V. Kondratovich
  FDA/CDRH/OPEQ/OIDRH/
  301-796-6036
  marina.kondratovich@fda.hhs.gov
 Leslie Landree
  FDA/OC/CDRH/OPEQ/OHTVII/DCTD/DB/
  301-796-6147
  leslie.landree@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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