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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 7-236
Standard
CLSI  M43-A October 2011
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
Scope/Abstract
This document contains standardized protocols for broth microdilution and agar dilution in vitro susceptibility testing for isolates of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma spp. It describes the optimum media formulations for use in broth microdilution and agar dilution assays for each species; provides minimal inhibitory concentration (MIC) quality control (QC) reference ranges for ATCC type strains; and offers recommendations for selection of antimicrobials for routine testing and MIC interpretive criteria for a limited number of drugs.

This guideline is intended for use by hospital clinical laboratories; reference microbiology laboratories; and government, industry, and academic research organizations that perform diagnostic testing and/or conduct research in mycoplasmal diseases that affect humans.
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.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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
§866.1700 Culture Media, Antimicrobial Susceptibility Test Class 2 LKA
Relevant FDA Guidance and/or Supportive Publications*
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.
FDA Technical Contacts
 Tonya Wilbon
  FDA/OC/CDRH/OCE/DICE/PCB/
  301-796-6224
  tonya.wilbon@fda.hhs.gov
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OIDRH/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
*These are provided as examples and others may be applicable.
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