510(k) DEN150059
DEN150059 is an FDA 510(k) premarket notification submitted by Clever Culture Systems AG for the device "APAS Compact with Urine Analysis Module". The FDA issued a decision of De Novo Granted on October 6, 2016. The device falls under product code PPU (Microbial Colony Image Assessment System), a Class II device regulated under 21 CFR 866.2190. Clever Culture Systems AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 6, 2016
- Date Received
- December 24, 2015
- Clearance Type
- Direct
- 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.