FDA Product Code JTN: Susceptibility Test Discs, Antimicrobial

Under FDA product code JTN, antimicrobial susceptibility test discs are cleared for disk diffusion testing in clinical microbiology laboratories.

These paper discs are impregnated with a specific concentration of an antibiotic and placed on an agar plate inoculated with the test organism. The diameter of the inhibition zone around each disc indicates whether the organism is susceptible, intermediate, or resistant to that antibiotic.

JTN devices are Class II medical devices, regulated under 21 CFR 866.1620 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Hardy Diagnostics and Oxoid Limited (Part of Thermo Fisher Scientific).