510(k) K251511
K251511 is an FDA 510(k) premarket notification submitted by Copan Wasp Srl for the device "PhenoMATRIX". The FDA issued a decision of Substantially Equivalent on January 22, 2026. The device falls under product code PPU (Microbial Colony Image Assessment System), a Class II device regulated under 21 CFR 866.2190. Copan Wasp Srl has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2026
- Date Received
- May 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microbial Colony Image Assessment System
- Device Class
- Class II
- Regulation Number
- 866.2190
- Review Panel
- MI
- Submission Type
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.