Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

009

Date of Entry 03/08/2004 

FR Recognition Number

7-89

Standard

CLSI  C39-A (Replaces C39-P)
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard

Scope/Abstract

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

  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.