| 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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7-262
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| Standard | |
CLSI M45 3rd Edition
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria |
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Scope/AbstractCLSI documents M02, M07, and M100 describe standardized methods and interpretive criteria for antimicrobial susceptibility testing of common aerobic bacteria, including some fastidious organisms. However, a number of less frequently encountered or fastidious bacteria are not addressed in those CLSI documents despite their potential to cause serious infections. M45 addresses these latter organisms with the goal of providing recommendations for clinical microbiology laboratories on how and when to determine the susceptibility of these diverse organisms. This document also provides guidance for public health laboratory testing of bacteria potentially associated with bioterrorism.
This edition of M45 includes taxonomic updates and several new tables to address organisms more likely to be identified in laboratories using sequencing or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry for the identification of bacteria. The intent of this revision is to assist laboratories in determining an approach for testing that is relevant to their individual practice settings.
The methods provided may be used in clinical, public health, and research laboratories.
This guideline does not address commercial susceptibility testing devices.
This edition of M45 includes taxonomic updates and several new tables to address organisms more likely to be identified in laboratories using sequencing or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry for the identification of bacteria. The intent of this revision is to assist laboratories in determining an approach for testing that is relevant to their individual practice settings.
The methods provided may be used in clinical, public health, and research laboratories.
This guideline does not address commercial susceptibility testing devices.
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Exceptions are noted on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm). In the absence of interpretive criteria and quality control parameters on this FDA webpage, consult the technical contacts below. |
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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.
This standard is recognized in part because:
Exceptions are noted on the FDA Antibacterial Susceptibility Test Interpretive Criteria webpage (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm). This webpage includes a table that lists antibacterial drugs and indicates which, if any, STIC are recognized or identified by FDA for that drug. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §866.1620 |
Susceptibility Test Discs, Antimicrobial
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Class 2
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JTN
|
| §866.1620 |
Discs, Elution
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Class 2
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LTX
|
| §866.1640 |
Susceptibility Test Powders, Antimicrobial
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Class 2
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JTT
|
| §866.1640 |
Manual Antimicrobial Susceptibility Test Systems
|
Class 2
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JWY
|
| §866.1640 |
Solution, Antimicrobial
|
Class 2
|
LOP
|
| §866.1640 |
Panels, Test, Susceptibility, Antimicrobial
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Class 2
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LTT
|
| §866.1640 |
Susceptibility Test Cards, Antimicrobial
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Class 2
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LTW
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| §866.1645 |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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Class 2
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LON
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| §866.1700 |
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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Class 2
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JSO
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| §866.1700 |
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
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Class 2
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JTZ
|
| §866.1700 |
Culture Media, Antimicrobial Susceptibility Test
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Class 2
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LKA
|
|
Relevant FDA Guidance and/or Supportive Publications*
FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm
Guidance for Industry and FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued August 2009.
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 Contacts
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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. |
