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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 7-262
Standard
CLSI M45 3rd Edition
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria.
Scope/Abstract
If a bacterial pathogen's susceptibility to antimicrobial agents cannot be predicted based on the identity of the organism alone, in vitro antimicrobial susceptibility testing of the isolated organism may be indicated. Susceptibility testing is particularly necessary in those situations in which the etiological agent belongs to a bacterial species for which resistance to commonly used antimicrobial agents has been documented, or could arise.

A variety of laboratory techniques can be used to measure the in vitro susceptibility of bacteria to antimicrobial agents. Clinical and Laboratory Standards Institute document M45--Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria describes the standard microdilution and agar disk diffusion methods. It also includes a series of procedures designed to standardize test performance. The performance, applications, and limitations of the current CLSI-recommended methods are described.

Extent of Recognition
Complete standard
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.

Interpretive criteria and quality control parameters are not recognized when different from that in FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria. See relevant guidance below for information on interpretive criteria.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§866.1700 Culture Media, Antimicrobial Susceptibility Test Class 2 LKA
§866.1700 Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Class 2 JSO
§866.1700 Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Class 2 JTZ
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
§866.1640 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Solution, Antimicrobial Class 2 LOP
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
§866.1640 Susceptibility Test Powders, Antimicrobial Class 2 JTT
§866.1620 Discs, Elution Class 2 LTX
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
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
FDA Technical Contact
 Ribhi Shawar
  FDA/OMPT/CDRH/OIR/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
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