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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 034 Date of Entry 01/30/2014 
FR Recognition Number 7-210
CLSI  H26-A2
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
This document provides guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers for manufacturers, end-user clinical laboratories, accrediting organizations, and regulatory bodies. In addition, end-user clinical laboratories will find guidance for establishment of clinically reportable intervals and for QA for preexamination and examination aspects of their systems.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 5.5.7 Medically Allowable Error

Section 5.6.1 Instrument Calibration

Section 5.6.2Whole Blood Cross-Checks
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Section 5.5.7 is in conflict with methods to estimate bias and confidence intervals, see article listed below.

Section 5.6.1 is in conflict with 21 CFR 820.72 (b)(1), see the regulation listed below.

Section 5.6.2 is in conflict with 21 CFR 820.72 (b)(1), see the regulation listed below.
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
§864.5200 Instrument, Automated Platelet Counting Class 2 GKX
§864.5200 Counter, Urine Particle Class 2 LKM
§864.5220 Counter, Differential Cell Class 2 GKZ
Relevant FDA Guidance and/or Supportive Publications*
Martin, R.L. (2000). General Deming Regression for Estimating Systematic Bias and Its Confidence Intervals in Method-Comparison Studies. Clinical Chemistry, 46(1):100-104.

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
 Takeesha Taylor-Bell
 Phu Tran
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.