510(k) · Cleared
ClearedBD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Kiestra B.V. · QQY Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Cleared on May 4, 2023 as substantially equivalent to K200839 (Clever Culture Systems, 2021) after a 580-day review. Its family tree reaches back 3 generations to 2016.
- Decided
- May 4, 2023
- Review
- 580 days
- Class
- Class II
- Product code
- QQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150059 (2016). No later device cites it as a predicate yet.
- Root · 3 generations backDEN150059 APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 2016
- 2 generations backK183648 APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 2019
- 1 generation backK200839 APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS…Clever Culture Systems · 2021
- This deviceK213280 BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA)…Bd Kiestra B.V. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN150059 | APAS Compact with Urine Analysis Module | Clever Culture Systems AG | 2016 | — |
| −2 | K183648 | APAS Independence with Urine Analysis Module | Clever Culture Systems AG | 2019 | — |
| −1 | K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS… | Clever Culture Systems | 2021 | — |
| 0 (this device) | K213280 | BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD… | Bd Kiestra B.V. | 2023 | — |
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 K200839 APAS Independence with IC Chromogenic MRSA BD…score 8.6 · 2 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 |
|---|---|---|---|
| * | K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC… Cleared while this submission was under review Summary page 7…pendence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module Predicate 510(k) Number: K200839 1 The term “substantial equivalence” as used in this 510(k) notification is limited to the definition of substantial equi… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K200839.
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. 2023, 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 BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is an in-vitro diagnostic software program that requires the BD Kiestra™ Laboratory Automation Solution in order to operate. The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is applied to digital images of BD BBL™ CHROMagar™ MRSA II culture plates inoculated with anterior nares samples. Algorithms are applied to digital images to provide a…
Read the full statement (210 words)
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is an in-vitro diagnostic software program that requires the BD Kiestra™ Laboratory Automation Solution in order to operate.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is applied to digital images of BD BBL™ CHROMagar™ MRSA II culture plates inoculated with anterior nares samples.
Algorithms are applied to digital images to provide a qualitative assessment of colony growth and colorimetric detection of target colonies for the detection of nasal colonization by MRSA and to serve as an aid in the prevention and control of MRSA infection. Applied algorithms provide the following results:
• “No growth”, which will be manually released individually or as a batch (with other no growth samples) by a trained microbiologist upon review of the digital plate images.
• “Growth - other” (growth without mauve color), which digital plate images will be manually reviewed by a trained microbiologist.
• “Growth MRSA Mauve” (growth with mauve color), which digital plate images will be manually reviewed by a trained microbiologist.
The assay is not intended to guide, diagnose, or monitor treatment for MRSA infections. It is not intended to provide results of susceptibility to oxacillin/methicillin.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is indicated for use in the clinical laboratory.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213280: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213280
Report an extraction error
Are you the manufacturer?
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