CLSI M07-A10

Standard Organization:

CLSI M07-A10
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard - Tenth Edition

Recognition Date	2015-08-14
Recognition List	040
Recognition Number	7-254
Extent	Partial recognition. The following part(s) of the standard is (are) not recognized Interpretive criteria and quality control parameters when different from that in FDA approved drug labels. In the absence of the interpretive criteria and quality control parameters in FDA approved drug labels, consult the technical contacts.
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,