Microbial Colony Image Assessment System
The Microbial Colony Image Assessment System is an instrument that assesses the presence or absence of microbial colonies on solid microbiological culture medium, interpreting their number, phenotypic, and morphologic characteristics, and providing semi-quantitative colony counts used as an aid in diagnosing urinary tract infections. It is classified as FDA Class 2 under 21 CFR 866.2190 in the Microbiology specialty, requiring 510(k) clearance. All urine culture plates identified as positive must be reviewed by a trained microbiologist. Product code PPU; eligible for third-party review; not an implant and not life-sustaining.
Research product code PPU in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PPU
- Device Class
- FDA class 2
- Regulation Number
- 866.2190
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251511 | PhenoMATRIX | Jan 22, 2026 | Substantially Equivalent | Copan Wasp Srl |
| K183648 | APAS Independence with Urine Analysis Module | May 15, 2019 | Substantially Equivalent | Clever Culture Systems AG |
| DEN150059 | APAS Compact with Urine Analysis Module | Oct 06, 2016 | Unknown | Clever Culture Systems AG |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.