CLSI H26-A2

Standard Organization:

CLSI H26-A2
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition

Recognition Date	2014-01-30
Recognition List	034
Recognition Number	7-210
Extent	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
Standards Orgs	CLSI Clinical Laboratory Standards Institute https://clsi.org/
STG	InVitro Diagnostics
FDA Tech	Takeesha Taylor-Bell FDA/OMPT/CDRH/OIR/DIHD/HEMB/ 240-402-6566 Takeesha.Taylor-Bell@fda.hhs.gov

Rationale:

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.

Scope:

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.

Code of Federal Regulations:

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
§864.5200	Counter, Cell, Automated (Particle Counter)	Class 2	GKL
§864.5200	Counter, Urine Particle	Class 2	LKM
§864.5200	Instrument, Automated Platelet Counting	Class 2	GKX
§864.5220	Counter, Differential Cell	Class 2	GKZ

FDA Guidance:

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.