PPUClass II

Microbial Colony Image Assessment System

21 CFR 866.2190 / Microbiology

PPU is the FDA product code for Microbial Colony Image Assessment System, a class II device type, regulated under 21 CFR 866.2190. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 2026-01-22, and no recalls.

Classification record

Product code: PPU
Device name: Microbial Colony Image Assessment System
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.
Regulation: 21 CFR 866.2190
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code PPU

By decision year

3 clearances under product code PPU with a decision year between 2016 and 2026, 2016 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PPU by decision year
Year	Clearances
2016	1
2019	1
2026	1

Applicants with the most clearances

Product code PPU

Applicants holding the most 510(k) clearances under product code PPU
Applicant	Clearances
Clever Culture Systems Limited	2
Copan WASP	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PPU

Recent recalls

Product code PPU

FDA records show no recalls under product code PPU.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)