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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 058 Date of Entry 05/30/2022 
FR Recognition Number 7-312
CLSI  M39 5th Edition
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
This guideline provides individuals involved with assessment of cumulative antimicrobial susceptibility test data with recommendations for the storage, analysis, and presentation of the data. The antimicrobial susceptibility test data from individual patient's isolates available for analysis are assumed to be final, accurate and in a usable format for health care providers. Recommendations cover the preparation of reports (eg, routine and enhanced antibiograms) to guide selection of empirical antimicrobial therapy. Reference to preparation of reports for other purposes is briefly discussed.

This guideline does not include procedures for selecting isolates for antimicrobial susceptibility testing (AST), performing AST, interpreting AST results, nor confirming the accuracy of AST results.
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.

NOTE: The veterinary section and practices included in this document do not apply to medical devices.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.2570 Instrumentation For Clinical Multiplex Test Systems Class 2 NSU
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§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
866.1650 Positive Blood Culture Identification And Ast Kit Class 2 PRH
§866.3365 Gram-Positive Bacteria And Their Resistance Markers Class 2 PAM
§866.3365 Fungal Organisms, Nucleic Acid-Based Assay Class 2 PEO
N/A Braf Mutation Kit PAN
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems

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 Contact
 Faiza Benahmed
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.