Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

050

Date of Entry 09/17/2018

FR Recognition Number

7-276

Standard

CLSI M38 3rd Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi

Scope/Abstract

This standard describes the reference broth microdilution testing method for antifungal susceptibility testing
of filamentous fungi (moulds) that cause invasive and/or cutaneous fungal infections.1-10 This standard also
covers testing conditions, including inoculum preparation and inoculum , incubation time and
temperature, media formulation, and end-point determination criteria.1-9 QC reference ranges and limits and
specific epidemiological cutoff values (ECVs) are summarized in the current editions of CLSI documents
M6118 and M59,12 respectively.

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
§866.1640	Susceptibility Test Powders, Antimicrobial	Class 2	JTT
§866.1640	Manual Antimicrobial Susceptibility Test Systems	Class 2	JWY
§866.1640	Reagent/Device, Inoculum Calibration	Class 2	LIE
§866.1640	Solution, Antimicrobial	Class 2	LOP
§866.1640	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Class 2	LRG
§866.1640	Panels, Test, Susceptibility, Antimicrobial	Class 2	LTT
§866.1640	Susceptibility Test Cards, Antimicrobial	Class 2	LTW
§866.1640	Susceptibility Test Powders, Antimycobacterial	Class 2	MJA
§866.1640	System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies	Class 2	MYI
§866.1640	Susceptibility Test Plate, Antifungal	Class 2	NGZ
§866.1640	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species	Class 2	NIJ
§866.1640	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Class 2	NQX
§866.1640	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony	Class 2	PMY
§866.1640	System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen	Class 2	POC
§866.1640	Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates	Class 2	PTJ
§866.1620	Susceptibility Test Discs, Antimicrobial	Class 2	JTN
§866.1620	Discs, Elution	Class 2	LTX
§866.1645	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Class 2	LON
§866.1700	Culture Media, Antifungal, Susceptibility Test	Class 2	MJE

Relevant FDA Guidance and/or Supportive Publications*

Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs Guidance for Industry, Issued December 2017.

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

Jeffrey Brocious

FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC2/

240-402-3797

jeffrey.brocious@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