Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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7-279
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Standard | |
CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
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Scope/AbstractThis standard describes standard broth (macrodiluation and microdiluation) and agar diluation emthods for determining in vitro susceptibility to antimicrobial agents for bacteria that grow aerobically. |
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of CLSI M07 11th Edition [Rec# 7-279] will be superseded by recognition of CLSI M07 12th Edition [Rec# 7-324]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-279] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 7-279] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§866.1640 |
Manual Antimicrobial Susceptibility Test Systems
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Class 2
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JWY
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§866.1640 |
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
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Class 2
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LRG
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§866.1640 |
Panels, Test, Susceptibility, Antimicrobial
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Class 2
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LTT
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§866.1640 |
Susceptibility Test Cards, Antimicrobial
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Class 2
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LTW
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§866.1645 |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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Class 2
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LON
|
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Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued March 5, 2007.
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 Contact
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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. |