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510(k) K183648

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
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)
  • DEN150059 — APAS Compact with Urine Analysis Module (October 6, 2016)

Other clearances for product code PPU

  • K251511 — PhenoMATRIX (January 22, 2026)
  • DEN150059 — APAS Compact with Urine Analysis Module (October 6, 2016)