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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 034 Date of Entry 01/30/2014 
FR Recognition Number 7-152
Standard
CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
Scope/Abstract
This document contains a protocol that optimizes the experimental design for the evaluation of qualitative tests, to better measure performance and provide a structured data analysis.
Extent of Recognition
Complete standard
Relevant FDA Guidance and/or Supportive Publications*
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, Issued March 2007.
FDA Technical Contacts
 Marina V. Kondratovich
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-6036
  marina.kondratovich@fda.hhs.gov
 Gene Pennello
  FDA/OC/CDRH/OSEL/DIDSR/
  301-796-6038
  gene.pennello@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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