Laboratory_medicine
APAS Independence with Urine Analysis Module
Clever Culture Systems AG
A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist.
FDA Submission Metadata
- Submission number
- K183648
- Decision date
- May 2019
- FDA panel
- Microbiology
- Product code
- PPU
- Clinical task (npj)
- diagnosis
- 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.
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