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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 7-253
Standard
CLSI EP15-A3 (Reaffirmed: September 2019)
User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
Scope/Abstract
This document describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed within as few as five days.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 862, 864 and 866 devices and their associated product code devices and 21 CFR 809
21 CFR HEMATOLOGY AND PATHOLOGY DEVICES
21 CFR 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES
FDA Technical Contacts
 Marina V. Kondratovich
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-6036
  marina.kondratovich@fda.hhs.gov
 Qin Li
  FDA/OC/CDRH/OPEQ/OCEA/DCEAII/
  301-796-5311
  qin.li@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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