• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 7-279
Standard
CLSI M07 11th Edition
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
Scope/Abstract
This standard describes standard broth (macrodiluation and microdiluation) and agar diluation emthods for determining in vitro susceptibility to antimicrobial agents for bacteria that grow aerobically.
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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§866.1640 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
Relevant FDA Guidance and/or Supportive Publications
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued March 5, 2007.
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
-
-