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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 7-281
Standard
CLSI M100, 29th ed. January 2019 (Replaces M100 28th ed). Performance Standards for Antimicrobial Susceptibility Testing
Scope/Abstract
This standard includes updated tables for the CLSI antimicrobial susceptibility testing standards M02-A13, M07-A11, and M11-A8.
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.
Transition Period
FDA recognition of M100 28th ed [Rec# 7-281] will be superseded by recognition of CLSI M100, 29th ed. January 2019 [Rec# 7-294]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-281] until December 27, 2020. After this transition period, declarations of conformity to [Rec# 7-281] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
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/OC/CDRH/OPEQ/OIDRH/DCTD/DB/
  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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