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CLSI POCT5 A : 1ED 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PERFORMANCE METRICS FOR CONTINUOUS INTERSTITIAL GLUCOSE MONITORING

Superseded date

03-27-2023

Published date

01-12-2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Point Accuracy
6 Trend Accuracy
7 Evaluating the Threshold Alarm
8 Device Stability
9 Calibration
10 Lag Time
11 Establishing Trueness of Measurement and Device Tracebility
References
Appendix A - Clinical Trials
Appendix B - R-Deviation - Numerical Accuracy Metric for Rate
             of Change in Process Measurement
Appendix C - Continuous Glucose- Error Grid Analysis (CG-EGA)
             - Metric fo CG-EGA
Summary of Delegate Comments and Committee Responses
The Quality Management System Approach
Related CLSI Reference Materials

Describes consensus guidelines for health care professionals, in vitro diagnostic (IVD) and medical device manufacturers, and regulatory agencies on how continuous glucose monitor (CGM) data should be: 1) presented; 2) compared between devices; and 3) compared between measurement technologies.

DevelopmentNote
Supersedes NCCLS POCT5 P. (01/2009)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

CLSI POCT6 : 1ED 2015 EFFECTS OF DIFFERENT SAMPLE TYPES ON GLUCOSE MEASUREMENTS

CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE

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