TABLE 3.

Terminology used in this minireview regarding breakpoints

Term	Definition
Current breakpoint	Breakpoints revised and published in the current CLSI M100 Standard (i.e., M100S 29th edition at the time of this writing)
Obsolete breakpoint	Breakpoints published in prior editions (i.e., as of this writing, M100S 28th edition and prior)
FDA-recognized breakpoint	Breakpoints listed on the FDA STIC website; www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm
Off-label breakpoint	Breakpoints used on a cASTs that are different than those FDA cleared on the cASTs
cASTs	Commercial antimicrobial susceptibility test system. In the United States, these include manual (disk and gradient diffusion) and automated devices. Manufacturers must use FDA CDER-recognized breakpoints
M100	CLSI standard that lists CLSI breakpoints, quality control ranges, antimicrobial agents recommended for testing and reporting and some additional information related to testing procedures
M23	CLSI guidance document that outlines the process and data required for approval of new breakpoints and revised breakpoints
STIC	Susceptibility test interpretive criteria; language used by the FDA for “breakpoint”
CDER	Center for Drug Evaluation and Research; branch of the FDA that regulates antimicrobial agents and breakpoints in the United States
CDRH	Center for Devices and Radiological Health; branch of the FDA that regulates medical devices in the United States, including cASTs