FDA Product Code LTT: Panels, Test, Susceptibility, Antimicrobial
Under FDA product code LTT, antimicrobial susceptibility test panels are cleared for the determination of minimum inhibitory concentrations in clinical microbiology.
These multi-well panels contain dilution series of multiple antibiotics used in broth microdilution testing to determine the MIC of each antibiotic against a clinical isolate, providing quantitative susceptibility data for antibiotic dosing and stewardship decisions.
LTT devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Beckman Coulter, Inc..
FDA 510(k) Cleared Panels, Test, Susceptibility, Antimicrobial Devices (Product Code LTT)
About Product Code LTT - Regulatory Context
510(k) Submission Activity
50 total 510(k) submissions under product code LTT since 1995, with 50 receiving FDA clearance (average review time: 108 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LTT have taken an average of 219 days to reach a decision - up from 101 days historically. Manufacturers should account for longer review timelines in current project planning.
LTT devices are reviewed by the Microbiology panel. Browse all Microbiology devices →