Who has the final call on antimicrobial breakpoints for automated testing cards?

Who has the final call on antimicrobial breakpoints for automated testing cards?

• A. CLSI
• B. FDA
• C. EMA
• D. WHO

Answer: (B)

Interpretive breakpoints define whether a bacterial isolate is susceptible, intermediate, or resistant to a drug. For automated testing cards, the breakpoints come from the organizations that publish these interpretive criteria. In the United States, CLSI is the primary source and sets the breakpoints used by most automated systems. In Europe, EUCAST provides the European criteria. The FDA’s role is regulatory: it clears and labels the device and evaluates performance against those breakpoints, but it does not set the breakpoint values itself. EMA and WHO do not prescribe device‑specific breakpoints for these tests. So the organization that provides the interpretive breakpoints used by automated cards is CLSI, with FDA functioning as the regulatory supervisor rather than the breakpoint author.

Interpretive breakpoints define whether a bacterial isolate is susceptible, intermediate, or resistant to a drug. For automated testing cards, the breakpoints come from the organizations that publish these interpretive criteria. In the United States, CLSI is the primary source and sets the breakpoints used by most automated systems. In Europe, EUCAST provides the European criteria. The FDA’s role is regulatory: it clears and labels the device and evaluates performance against those breakpoints, but it does not set the breakpoint values itself. EMA and WHO do not prescribe device‑specific breakpoints for these tests. So the organization that provides the interpretive breakpoints used by automated cards is CLSI, with FDA functioning as the regulatory supervisor rather than the breakpoint author.