510(k) · Cleared
ClearedAPAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clever Culture Systems · QQY Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Cleared on Oct 28, 2021 as substantially equivalent to K183648 (Clever Culture Systems AG, 2019) after a 576-day review. Its family tree reaches back 2 generations to 2016. 2 later devices descend from it.
- Decided
- Oct 28, 2021
- Review
- 576 days
- Class
- Class II
- Product code
- QQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150059 (2016). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN150059 APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 2016
- 1 generation backK183648 APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 2019
- This deviceK200839 APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS…Clever Culture Systems · 2021
- Descendant · cites it directly · 0 of its ownK251511 PhenoMATRIXCopan Wasp Srl · 2026
- Descendant · cites it directly · 0 of its ownK213280 BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA)…Bd Kiestra B.V. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN150059 | APAS Compact with Urine Analysis Module | Clever Culture Systems AG | 2016 | — |
| −1 | K183648 | APAS Independence with Urine Analysis Module | Clever Culture Systems AG | 2019 | — |
| 0 (this device) | K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS… | Clever Culture Systems | 2021 | — |
| +1 | K251511 | PhenoMATRIX | Copan Wasp Srl | 2026 | — |
| +1 | K213280 | BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD… | Bd Kiestra B.V. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QQY device
- #1 K213280 BD Kiestra Methicillin-resistant…score 5.9 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183648 | APAS Independence with Urine Analysis ModuleSummary page 4…ontrols). Product Code QQY 5.3 Predicate Device The predicate device is APAS Independence with Urine Analysis Module, K183648. This predicate has not been subject to a design related recall. The information contained herein this document is the proper… | 2019 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K251511 (Copan Wasp Srl, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K183648.
How does its category compare?
All QQY devicesQQY Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QQY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QQY
Too few QQY 510(k)s in any year since 2007 to give a median.
Recalls per year · QQY
No recall names QQY since 2007.
Adverse event reports per year · QQY
No MAUDE report names QQY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (274 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200839 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200839: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200839
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026