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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 009 Date of Entry 03/08/2004 
FR Recognition Number 7-86
Standard
CLSI  C29-A2 (Replaces C29-A)
Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
Scope/Abstract
This standard contains recommendations for the expression of results of ion-selective electrode measurement of sodium and potassium ion activities in undiluted serum, plasma, or whole blood in clinical practice.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1600 Electrode, Ion Specific, Potassium Class 2 CEM
§862.1665 Electrode, Ion Specific, Sodium Class 2 JGS
Relevant FDA Guidance and/or Supportive Publications*
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.

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
 Tracey Bosworth
  FDA/OC/CDRH/OPEQ/OCEA/DCEAI/
  301-796-2981
  Tracey.Bosworth@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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