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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 020 Date of Entry 09/09/2008 
FR Recognition Number 7-163
Standard
CLSI  H56-A (Replaces H56-P)
Body Fluid Analysis for Cellular Composition; Approved Guideline.
Scope/Abstract
This guideline provides users with recommendations for collection and transport of body fluids, numeration and identification of cellular components, and guidance for qualitative and quantitative assessment of body fluid.
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
§864.5220 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 Contact
 Takeesha Taylor-Bell
  FDA/OC/CDRH/OPEQ/OIDRH/DIHD/HB/
  240-402-6566
  Takeesha.Taylor-Bell@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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