# DEN150059: APAS Compact with Urine Analysis Module

- Pathway: De Novo (Direct)
- Applicant: Clever Culture Systems AG
- Decided: Oct 6, 2016 after 287 days
- Product code: PPU (Microbial Colony Image Assessment System)
- Device class: 2
- Regulation: 21 CFR 866.2190
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K183648: APAS Independence with Urine Analysis Module (2019), 3 descendants of its own
- K200839: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (2021), 2 descendants of its own
- K251511: PhenoMATRIX (2026), 0 descendants of its own
- K213280: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application,  BD Kiestra MRSA App (2023), 0 descendants of its own

## Indications for use
The APAS Compact is an in vitro diagnostic system comprised of an instrument for automated imaging of agar culture plates and a software analysis module for the following use: The APAS Compact, when using its urine analysis module, automates urine culture plate imaging and interpretation to detect the presence or absence of microbial growth on sheep blood and MacConkey agar culture plates that are inoculated with a 1µL sample volume. The APAS Compact, when using its urine analysis module, 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.

Source page: https://510kreport.com/device/DEN150059
Methodology: https://510kreport.com/methodology