Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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7-307
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Standard | |
CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring |
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Scope/AbstractThis guideline provides recommendations for methods used to determine analytical and clinical metrics of continuous glucose monitoring (CGM) as an indicator of blood glucose values. It discusses use cases, point accuracy, trend accuracy, evaluation of threshold alerts, system stability and reliability, clinical studies for assessing CGM performance, calibration, traceability of measurement, cybersecurity, and device labeling.
The intended users of this guideline are in vitro diagnostic and medical device manufacturers, regulatory agencies, and health care professionals. This guideline is not intended for use by patients and does not discuss devices that do not meet the definitions of continuous, interstitial, and glucose monitoring.
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§862.1355 |
Integrated Continuous Glucose Monitoring System, Factory Calibrated
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Class 2
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QBJ
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§862.1355 |
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
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Class 2
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QDK
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§862.1355 |
Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
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Class 2
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QDL
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§862.1355 |
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
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Class 2
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QLG
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N/A |
Sensor, Glucose, Invasive |
Class 3
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MDS
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N/A |
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
Class 3
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OYC
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N/A |
Automated Insulin Dosing , Threshold Suspend |
Class 3
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OZO
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N/A |
Automated Insulin Dosing Device System, Single Hormonal Control |
Class 3
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OZP
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N/A |
Continuous Glucose Monitor, Implanted, Adjunctive Use |
Class 3
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QCD
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N/A |
Sensor, Glucose, Implanted, Non-Adjunctive Use |
Class 3
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QHJ
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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