Home / 510(k) Clearances / DEN150059

510(k) DEN150059

APAS Compact with Urine Analysis Module by Clever Culture Systems AG — Product Code PPU

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.

Other clearances by Clever Culture Systems AG

  • K200839 — APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence (October 28, 2021)
  • K183648 — APAS Independence with Urine Analysis Module (May 15, 2019)

Other clearances for product code PPU

  • K251511 — PhenoMATRIX (January 22, 2026)
  • K183648 — APAS Independence with Urine Analysis Module (May 15, 2019)