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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 030 Date of Recognition 01/15/2013 
FR Recognition Number 7-236
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline.
This document provides guidelines for performance, interpretation, and quality control of in vitro broth microdilution and agar dilution susceptibility tests for several antimicrobial agents suitable for use against Mycoplasma pneumoniae (M. pneumoniae), Mycoplasma hominis (M. hominis), and Ureaplasma species (Ureaplasma spp). Information in this document includes designated reference strains and the expected minimal inhibitory concentration ranges for specific drugs that should be obtained when they are tested.
Extent of Recognition
Complete standard
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
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.
FDA Technical Contact
 Tonya Wilbon
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics