PPU
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Microbial Colony Image Assessment System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2190
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| PhenoMATRIX (K251511) | Copan Wasp Srl | 2026-01-22 |
| APAS Independence with Urine Analysis Module (K183648) | Clever Culture Systems AG | 2019-05-15 |
| APAS Compact with Urine Analysis Module (DEN150059) | Clever Culture Systems AG | 2016-10-06 |
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Every clearance here is in the API, with alerts when new ones post.