FDA Product Code JWY: Manual Antimicrobial Susceptibility Test Systems
FDA product code JWY covers manual antimicrobial susceptibility test systems.
These diagnostic systems are used to determine which antibiotics are effective against specific bacterial or fungal isolates from patient samples. Results guide clinicians in selecting appropriate antibiotic therapy, a critical step in managing infections and combating antimicrobial resistance.
JWY devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Thermo Fisher Scientific, Liofilchem S. R. L. and Beckman Coulter, Inc..
FDA 510(k) Cleared Manual Antimicrobial Susceptibility Test Systems Devices (Product Code JWY)
About Product Code JWY - Regulatory Context
510(k) Submission Activity
441 total 510(k) submissions under product code JWY since 1981, with 441 receiving FDA clearance (average review time: 89 days).
Submission volume has increased in recent years - 22 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JWY have taken an average of 117 days to reach a decision - up from 88 days historically. Manufacturers should account for longer review timelines in current project planning.
JWY devices are reviewed by the Microbiology panel. Browse all Microbiology devices →