# K200839: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module

- Pathway: 510(k) (Traditional)
- Applicant: Clever Culture Systems
- Decided: Oct 28, 2021 after 576 days
- Product code: QQY (Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms)
- 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
Longest line of descent: 2 generations back to DEN150059 (2016). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K183648: APAS Independence with Urine Analysis Module, Clever Culture Systems AG (2019) Summary page 4.

## Most influential descendants
- 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 Independence is an in vitro diagnostic system comprised of an instrument for automated imaging of agar plates and a software analysis module for the following uses: 1. The APAS Independence, when using its IC MRSA Chromogenic BD Analysis Module, automates culture plate imaging and interpretation to detect the presence or absence of colonies with colors suggestive of methicillin-resistant Staphylococcus aureus (MRSA) growth on Beckton Dickson BBL™ CHROMagar™ MRSA 1I agar that has been inoculated with anterior nares swabs and incubated at 36°C & 1°C for 24 hours. The APAS Independence, when using its IC MRSA Chromogenic BD Analysis Module, provides an aid in routine screening for colonization with MRSA. It provides one of two screening results: Presumptive MRSA or Negative. All culture plates that are identified as Presumptive MRSA by the APAS Independence, when using the IC MRSA Chromogenic BD Analysis Module require review by a trained microbiologist. 2. The APAS Independence, when using its [IC MRSA Chromogenic TFS/S Analysis Module, automates culture plate imaging and interpretation to detect the presence or absence of colonies with colors suggestive of methicillin-resistant Staphylococcus aureus (MRSA) growth on Thermo-Fisher Spectra™ MRSA agar that has been inoculated with anterior nares swabs and incubated at 36°C = 1°C for 24 hours. The APAS Independence, when using its IC MRSA Chromogenic TFS/S Analysis Module, provides an aid in routine screening for colonization with MRSA. It provides one of three screening results: Presumptive MRSA, Presumptive non-MRSA, or Negative. All culture plates that are identified as Presumptive MRSA or Presumptive non-MRSA by the APAS Independence, when using the IC MRSA Chromogenic TFS/S Analysis Module, require review by a trained microbiologist.

Source page: https://510kreport.com/device/K200839
Methodology: https://510kreport.com/methodology