CLSI M38 3rd Edition

Reference Method For Broth Dilution Antifungal Susceptibility Testing Of Filamentous Fungi

M38 3rd Edition

Standard Organization: CLSI

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

Recognition NumberInVitro Diagnostics
Recognition Date2018-09-17
Recognition List050
Recognition Number7-276
Extent Complete standard
Standards Orgs CLSI Clinical Laboratory Standards Institute https://clsi.org/
STG InVitro Diagnostics
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard includes antifungal agent selection, preparation of antifungal stock solutions and dilutions for testing, test procedure implementation and interpretation, and quality control requirements for susceptibility testing of filamentous fungi (moulds) that cause invasive and cutaneous fungal infections.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
§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
§866.1700 Culture Media, Antifungal, Susceptibility Test Class 2 MJE

FDA Guidance:

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

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