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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 021 Date of Entry 03/18/2009 
FR Recognition Number 7-71
CLSI  H15-A3 (Replaces H15-A2)
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
This document describes the principle, materials, and procedure for reference and standardized hemoglobin determinations. It includes specifications for secondary hemiglobincyanide (HiCN) standards.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.5200 Counter, Cell, Automated (Particle Counter) Class 2 GKL
§864.5620 System, Hemoglobin, Automated Class 2 GKR
§864.8165 Calibrator For Hemoglobin And Hematocrit Measurement Class 2 KRZ
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
 Jeb Monasterial
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.