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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 7-87
Standard
CLSI  C31-A2 (Replaces C31-A)
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
Scope/Abstract
This document addresses preanalytical considerations--such as patient condition, specimen choice, collection, and handling--that can influence accuracy and clinical utility of ionized calcium measurements.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1145 Electrode, Ion Specific, Calcium Class 2 JFP
§862.1145 Cresolphthalein Complexone, Calcium Class 2 CIC
§862.1145 Azo Dye, Calcium Class 2 CJY
§862.1145 Atomic Absorption, Calcium Class 2 JFN
Relevant FDA Guidance and/or Supportive Publications*
Points to 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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