| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
052
|
Date of Entry 07/15/2019
|
|
FR Recognition Number
|
7-287
|
| Standard | |
CLSI M44-S3 (2018)
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement |
|
Scope/Abstract| This standard provides approved zone interpretive criteria (breakpoints) for Candida species for caspofungin, fluconazole, and voriconazole after 20 to 24 hours incubation, as well as quality control parameters for caspofungin, fluconazole, posaconazole, and voriconazole. There are currently more than 10 systemically active antifungal agents, and it is expected that this document will further encourage the development of disk diffusion testing for at least some of these additional agents and genera. |
|
| Extent of Recognition
|
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 |
| §866.1620 |
Susceptibility Test Discs, Antimicrobial
|
Class 2
|
JTN
|
| §866.1620 |
Discs, Elution
|
Class 2
|
LTX
|
| §866.1640 |
Susceptibility Test Plate, Antifungal
|
Class 2
|
NGZ
|
| §866.1700 |
Culture Media, Antifungal, Susceptibility Test
|
Class 2
|
MJE
|
|
Relevant FDA Guidance and/or Supportive Publications*
| 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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
