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., Dade Microscan, Inc. and Pasco Laboratories, Inc..