Devices · Clever Culture Systems AG

APAS Independence with Urine Analysis Module

Clever Culture Systems AG is listed for APAS Independence with Urine Analysis Module (K183648). The FDA list gives May 15, 2019 as the date of the final decision. The lead panel is Microbiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PPU as “Microbial Colony Image Assessment System”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183648

Official FDA database record

Date of final decision

May 15, 2019

Company on the FDA list

Clever Culture Systems AG

Lead panel

Microbiology

Primary product code

PPU

openFDA device name for the code

Microbial Colony Image Assessment System

Device class

2

Regulation number

866.2190

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary