Laboratory_medicine
Accelerate Pheno System, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc.
FDA-cleared AI medical device
Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
FDA Submission Metadata
- Submission number
- K192665
- Decision date
- September 2020
- FDA panel
- Microbiology
- Product code
- PRH
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.