FDA Product Code NGZ: Susceptibility Test Plate, Antifungal
Fungal infections pose a significant and growing challenge in immunocompromised patients. FDA product code NGZ covers antifungal susceptibility test plates.
These devices contain panels of antifungal agents in microbroth dilution format to determine the minimum inhibitory concentration of antifungals against fungal isolates from clinical specimens. Results guide selection of antifungal therapy in invasive candidiasis, aspergillosis, and other serious fungal infections.
NGZ 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 and bioMerieux, Inc..
FDA 510(k) Cleared Susceptibility Test Plate, Antifungal Devices (Product Code NGZ)
About Product Code NGZ - Regulatory Context
510(k) Submission Activity
21 total 510(k) submissions under product code NGZ since 2001, with 21 receiving FDA clearance (average review time: 231 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
FDA review times for NGZ submissions have been consistent, averaging 203 days recently vs 236 days historically.
NGZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →