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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 7-145
CLSI  H42-A2 (Replaces H42-A)
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
This standard was developed to address issues of procedures and quality assurance for clinical applications of flow cytometry. It is designed to aid clinical laboratorians in the development of quality assurance procedures and to establish the foundation for different laboratories using different commercially available instruments to obtain comparable results. Specific topics covered include: specimen collection, transport, and preparation; sample quality control and staining procedures; instrument calibration; sample analysis, and data analysis, storage, and reporting.
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 Contact
 Jacqueline Cleary
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.