FDA product code PPU: Microbial Colony Image Assessment System
PPU is the FDA product code for microbial colony image assessment system. It is a Class II device, regulated under 21 CFR 866.2190 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under PPU, 1 in the last five years, from 2 different applicants. The average 510(k) review took 196 days (median 196); 251 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Microbial Colony Image Assessment System |
| Device class | Class II |
| Regulation | 21 CFR 866.2190 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PPU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 140 |
| 2026 | 1 | 251 |
Compare with all 510(k) review times · Search every PPU clearance
Top PPU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Copan Wasp Srl | 1 | 2026-01-22 |
| Clever Culture Systems AG | 1 | 2019-05-15 |
Most recent PPU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251511 | Copan Wasp Srl | PhenoMATRIX | 2026-01-22 | 251 |
| K183648 | Clever Culture Systems AG | APAS Independence with Urine Analysis Module | 2019-05-15 | 140 |
Recalls for PPU devices
openFDA lists no recalls for product code PPU.
Frequently asked questions
What is FDA product code PPU?
PPU is the FDA product code for microbial colony image assessment system. It is a Class II device, regulated under 21 CFR 866.2190 and reviewed by the Microbiology panel.
What device class is PPU?
Class II, regulation 21 CFR 866.2190. Typical premarket route: 510(k).
How long does a 510(k) take for product code PPU?
Across 2 cleared submissions the average was 196 days from receipt to decision (median 196).
Which companies have the most PPU clearances?
Copan Wasp Srl (1); Clever Culture Systems AG (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PPU
- Run a recall and safety report across every PPU manufacturer
- Watch product code PPU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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