CLSI M100 27th Edition (Replaces M100-S26)

Performance Standards For Antimicrobial Susceptibility Testing

M100 27th Edition (Replaces M100-S26)

Standard Organization: CLSI

CLSI M100 27th Edition (Replaces M100-S26)
Performance Standards for Antimicrobial Susceptibility Testing

Recognition Number	InVitro Diagnostics
Recognition Date	2018-06-07
Recognition List	049
Recognition Number	7-271
Extent	Partial recognition. The following part(s) of the standard is (are) not recognized Noted exceptions on the Antimicrobial Susceptibility Test Interpretive Criteria website: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm.
Standards Orgs	CLSI Clinical Laboratory Standards Institute https://clsi.org/
STG	InVitro Diagnostics
FDA Tech	Ribhi Shawar FDA/OMPT/CDRH/OIR/DMD/BAC1/ 301-796-6698 ribhi.shawar@fda.hhs.gov

Rationale:

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Scope:

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	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Class 2	LRG
§866.1640	Manual Antimicrobial Susceptibility Test Systems	Class 2	JWY
§866.1640	Panels, Test, Susceptibility, Antimicrobial	Class 2	LTT
§866.1640	Susceptibility Test Cards, Antimicrobial	Class 2	LTW

FDA Guidance:

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued March 2007.