Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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7-325
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Standard | |
CLSI M02 14th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests |
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Scope/AbstractThis standard describes the reference disk diffusion method used to determine the in vitro antimicrobial susceptibility of bacteria that grow aerobically and includes: - Agar plate preparation - Testing conditions, including inoculum preparation and standardization, incubation time, and incubation temperature - Results interpretation - QC procedures - Disk diffusion method limitations To assist the medical laboratory, recommendations are provided for selecting antimicrobial agents for routine testing and reporting... |
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Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized: |
Appendix E. Test for Performing Disk Diffusion Directly from Positive Blood Culture Broth
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Rationale for Recognition
Appendix E. is in conflict with an existing regulation, 21 CFR 866.1620, which states bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface rather than positive blood culture broth directly on an agar surface. |
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Transition Period
FDA recognition of CLSI M02 13th Edition [Rec# 7-280] will be superseded by recognition of CLSI M02 14th Edition [Rec# 7-325]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-280] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 7-280] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§866.1620 |
Susceptibility Test Discs, Antimicrobial
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Class 2
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JTN
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§866.1620 |
Discs, Elution
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Class 2
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LTX
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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
Guidance for Industry and FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, issued August 2009.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |