PPU — Microbial Colony Image Assessment System Class II

FDA Device Classification

Classification Details

Product Code
PPU
Device Class
Class II
Regulation Number
866.2190
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251511copan waspPhenoMATRIXJanuary 22, 2026
K183648clever culture systemsAPAS Independence with Urine Analysis ModuleMay 15, 2019
DEN150059clever culture systemsAPAS Compact with Urine Analysis ModuleOctober 6, 2016