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510(k) K251511

PhenoMATRIX by Copan Wasp Srl — Product Code PPU

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.

Other clearances by Copan Wasp Srl

  • K232756 — Colibrí (December 27, 2023)
  • K223245 — Colibrí (March 20, 2023)
  • K220546 — Colibrí System (October 5, 2022)
  • K193138 — Colibri System (December 27, 2021)

Other clearances for product code PPU

  • K183648 — APAS Independence with Urine Analysis Module (May 15, 2019)
  • DEN150059 — APAS Compact with Urine Analysis Module (October 6, 2016)