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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 7-291
Standard
CLSI EP27-A
How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
Scope/Abstract
This guideline describes what an error grid is, why it is useful, and how to construct and interpret the information. Guidance is provided for manufacturers and for the clinical laboratory.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
5.9 Goals or Acceptance Criteria
5.10.2 Sample
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.

Sections 5.9 and 5.10.2 are in conflict with another recognized standard. See CLSI EP21 2nd Edition, ID Section, listed below.
Relevant FDA Guidance and/or Supportive Publications*
CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures.
FDA Technical Contacts
 Leslie Landree
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/DB/
  301-796-6147
  leslie.landree@fda.hhs.gov
 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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