Antibacterial Susceptibility Test Interpretive Criteria | FDA
Feb 7, 2025 · The table below lists antibacterial drugs and indicates which, if any, susceptibility test interpretive criteria, also known as “breakpoints” (abbreviated as STIC), are recognized or ...
FDA-Recognized Antimicrobial Susceptibility Test Interpretive …
Jun 21, 2023 · STIC are the criteria used to interpret AST results. STIC identify whether bacteria or fungi are considered susceptible or resistant to a particular drug. Bacteria and fungi change over time.
Notices of updates to FDA STIC determinations
Feb 12, 2025 · FDA has updated STIC (MIC and disk diffusion) for Enterobacterales. FDA has recognized M100 standard for susceptible and resistant breakpoints and updated an intermediate breakpoint.
Updating Breakpoints in Antimicrobial Susceptibility Testing
Check the breakpoints posted on the FDA STIC website if they do not match with CLSI M100 or EUCAST. If the breakpoints routinely reported by the laboratory do not match CLSI, EUCAST or FDA, they are obsolete and must be updated to at least 2021 breakpoints before Jan. 1, 2024.
FDA Publishes Breakpoint Resources | News | CLSI
Dec 14, 2017 · The website provides information on the most up-to-date Susceptibility Test Interpretive Criteria (STIC), also known as breakpoints. Breakpoints help determine whether a specific bacteria or fungi are susceptible to (ie, will respond to treatment with) antibacterial or antifungal drugs.
Major updates to FDA-recognized Clinical and Laboratory …
2 days ago · Starting in 2006, the FDA started to require the use of FDA-recognized susceptibility test interpretive criteria (STIC), also known as breakpoints, on FDA-cleared devices. Historically, the use of either CLSI or FDA breakpoints was accepted by the FDA . For many years, this distinction was not an issue, as (1) FDA and CLSI breakpoints were ...
Recognized Consensus Standards: Medical Devices - accessdata.fda.gov
Dec 23, 2024 · This webpage includes a table that lists antibacterial drugs and indicates which, if any, STIC are recognized or identified by FDA for that drug. Transition Period FDA recognition of CLSI M100,...
Notice of Updates – FDA Recognized Antimicrobial Susceptibility …
Feb 14, 2025 · FDA has updated the STIC website with breakpoint information for the following: Antibacterial Susceptibility Test Interpretive Criteria https://www.fda.gov/drugs/development-resources/antibacterial-susceptibility-test-interpretive-criteria
Federal Register :: Antimicrobial Susceptibility Test System …
Sep 29, 2023 · This guidance describes approaches for AST system device sponsors to adopt updated breakpoints recognized on the STIC website (FDA-Recognized Antimicrobial Susceptibility Test Interpretative Criteria) and associated performance data in device labeling to facilitate the timely availability of devices with the most up-to-date STIC for patient ...
FDA adds breakpoint updates to antimicrobial susceptibility test
Oct 2, 2023 · The US Food and Drug Administration (FDA) has updated its final guidance on antimicrobial susceptibility test (AST) system device labeling based on breakpoint updates through the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria (STIC) website.