# K213280: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application,  BD Kiestra MRSA App

- Pathway: 510(k) (Traditional)
- Applicant: Bd Kiestra B.V.
- Decided: May 4, 2023 after 580 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: 3 generations back to DEN150059 (2016). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200839: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module, Clever Culture Systems (2021). Cleared while this submission was under review Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K213280
Methodology: https://510kreport.com/methodology