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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 046 Date of Entry 12/23/2016 
FR Recognition Number 7-267
Standard
CLSI  C24 4th Edition (Replaces C24-A3)
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
Scope/Abstract
This guideline provides definitions, principles, and approaches to laboratory quality control design, implementation, and assessment.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1660 Single (Specified) Analyte Controls (Assayed And Unassayed) Class 1 JJX
§862.1660 Multi-Analyte Controls, All Kinds (Assayed) Class 1 JJY
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
 Lili Duan
  FDA/OC/CDRH/OPEQ/ORP/
  301-796-7404
  lili.duan@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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