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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 028 Date of Entry 03/16/2012 
FR Recognition Number 7-150
Standard
CLSI  H43-A2
Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
Scope/Abstract
This document provides performance guidelines for the immunophenotypic analysis of neoplastic hematolymphoid cells using immunofluorescence-based flow cytometry; for sample and instrument quality control; and precautions for acquisition of data from neoplastic hematolymphoid cells.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.5220 Counter, Differential Cell Class 2 GKZ
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA, Issued December 2001.

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 Contacts
 Kevin Maher
  FDA/OC/CDRH/OPEQ/OIDRH/DIHD/IMFB/
  301-796-6879
  kevin.maher@fda.hhs.gov
 Jobert Barin
  FDA/CDRHOPEQ/OHT7/
  --
  jobert.barin@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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