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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 7-89
CLSI  C39-A (Replaces C39-P)
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
This document describes a designated comparison method to standardize the ionized calcium measurements made by ion-selective electrode (ISE) potentiometry.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1145 Cresolphthalein Complexone, Calcium Class 2 CIC
§862.1145 Azo Dye, Calcium Class 2 CJY
§862.1145 Atomic Absorption, Calcium Class 2 JFN
§862.1145 Electrode, Ion Specific, Calcium Class 2 JFP
§862.1150 Calibrator, Primary Class 2 JIS
§862.1150 Calibrator, Secondary Class 2 JIT
§862.1150 Calibrator, Multi-Analyte Mixture Class 2 JIX
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
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.