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 Hardy Diagnostics, Becton, Dickinson and Company and Thermo Fisher Scientific (Oxoid Ltd.).
FDA 510(k) Cleared Susceptibility Test Discs, Antimicrobial Devices (Product Code JTN)
About Product Code JTN - Regulatory Context
510(k) Submission Activity
327 total 510(k) submissions under product code JTN since 1976, with 327 receiving FDA clearance (average review time: 65 days).
Submission volume has remained relatively stable over the observed period, with 8 submissions in the last 24 months.
FDA Review Time
Recent submissions under JTN have taken an average of 97 days to reach a decision - up from 65 days historically. Manufacturers should account for longer review timelines in current project planning.
JTN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →