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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 7-261
CLSI M23 Fourth Edition (Replaces M23-A3) Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters.
This document offers guidance for developing interpretive criteria and QC ranges for antimicrobial susceptibility tests against aerobic and anaerobic bacteria, and selected fungi performed by CLSI antimicrobial susceptibility testing standards. It describes the data used by the Subcommittees on Antimicrobial Susceptibility Testing and Antifungal Susceptibility Tests to establish these interpretive criteria and QC ranges for antimicrobial agents, including microbiological data, pharmacokinetic and pharmacodynamic characteristics, and clinical data. As antimicrobial agents are used in practice, additional experience accrued may be used to reassess interpretive criteria or QC ranges. Users of these guidelines should understand that susceptibility test results cannot predict clinical outcomes with absolute certainty. They should be used along with the best clinical judgment and laboratory support to draw the best conclusions to serve the patient.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Reagent/Device, Inoculum Calibration Class 2 LIE
§866.1640 Solution, Antimicrobial Class 2 LOP
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1640 Susceptibility Test Powders, Antimicrobial Class 2 JTT
§874.4420 Press, Vein Class 1 JYW
§866.1620 Discs, Elution Class 2 LTX
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
FDA Technical Contact
 Ribhi Shawar
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.