(580 days)
Not Found
No
The document describes the use of "Algorithms" and "Image Algorithms" for image processing and classification, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The description of the algorithms' function suggests rule-based or traditional image analysis techniques rather than learned models.
No
This device is an in-vitro diagnostic software program that assists in the detection of nasal colonization by MRSA. It explicitly states, "The assay is not intended to guide, diagnose, or monitor treatment for MRSA infections." This indicates it's an diagnostic aid, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is an in-vitro diagnostic software program." It also describes its purpose as providing a qualitative assessment for the detection of nasal colonization by MRSA.
No
The device is described as a "software program" but explicitly states it "requires the BD Kiestra™ Laboratory Automation Solution in order to operate." This indicates a dependency on specific hardware components (the automation solution) for its function, making it not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is an in-vitro diagnostic software program. It is used to analyze digital images of culture plates inoculated with patient samples (anterior nares) to detect nasal colonization by MRSA. This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Specimen Type: The device analyzes digital images of culture plates inoculated with anterior nares samples, which are specimens derived from the human body.
- Purpose: The purpose is 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. While it's not intended for diagnosis or treatment monitoring, aiding in detection and prevention/control falls under the scope of IVD use.
- Clinical Laboratory Use: The device is indicated for use in the clinical laboratory, a typical setting for IVD testing.
The fact that it's a software program that analyzes images and requires a laboratory automation solution does not preclude it from being an IVD. The key is its intended use in examining human specimens to provide information for diagnostic or related purposes.
N/A
Intended Use / 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.
Product codes
QQY
Device Description
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will be optional for the BD Kiestra™ Laboratory Automation Solution and will support laboratory technologists in batching no growth on the BD BBL™ CHROMagar™ MRSA II, growth with no key colony color detected for MRSA ("Growth – other"), and growth with key colony color detected for MRSA ("Growth MRSA Mauve"). These classifications will be characterized as "no growth" and "growth with mauve color" from BD BBLTM CHROMagar™ MRSA II media, from anterior nares samples.
The technologist has the ability to create work lists in BD Synapsys™ informatics solution based on the classifications (growth, no growth or growth with mauve color). These work lists will be used for followup work and batching of results, at the sample level.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will apply Image Algorithms to the digital images to determine if the plate contains "growth" or "no growth". At the individual plate level when the Image Algorithms detects colony growth and potential mauve color the classification will be "growth with mauve color".
When the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is not capable of automatically generating the outputs (visual attributes: growth with or without mauve color/no growth), the laboratory technologist will be required to read the digital image of the plate on the computer screen and decide on follow-up action as is the current standard laboratory practice.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light Emitting Diode (LED) illumination
Anatomical Site
anterior nares
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Digital Quality Image Study:
Study Type: Internal digital image quality study
Sample Size: 521 samples
Data Source: simulated surveillance samples including MRSA, non-MRSA, and saline controls, plated on BD BBL™ CHROMagar™ MRSAII agar, incubated, and imaged using the BD Kiestra™ Laboratory Automation Solution. Digital images were acquired using the BD Kiestra™ ReadA Compact with 5 MP camera.
Annotation Protocol: Three trained clinical microbiologists evaluated plates manually and from the digital image. Samples were randomized and readers did not have access to the direct plate when reading digital images. Results were categorized as mauve growth, non-mauve growth, or no growth.
Key Results:
Combined Percent Agreement between Manual Plate Reading and Digital Image Reading:
No Growth: 93.1% (148/159)
Non-Mauve Growth: 98.3% (169/172)
Mauve Growth: 98.9% (188/190)
Digital Image Reproducibility:
Study Type: Internal reproducibility study
Sample Size: 518 results (3 excluded due to invalid results from at least one microbiologist)
Data Source: Digital images from the digital image quality study.
Annotation Protocol: Analysis was performed by comparing each microbiologist's interpretation to the final digital image result (determined by 2/3 majority microbiologist result) to calculate percent agreement.
Key Results:
Combined Reproducibility of Digital Image Reading Results with 2/3 majority:
No Growth: 98.0% (150/153)
Non-Mauve Growth: 100% (175/175)
Mauve Growth: 98.9% (188/190)
Reproducibility (Seeded Samples):
Study Type: Internal reproducibility study with seeded samples
Sample Size: Not explicitly stated for total samples, but results are given per dilution and organism across two sites.
Data Source: Seeded samples representing MRSA positive (mauve) and MRSA negative (non-mauve) isolates, prepared with saline using 18-24-hour bacterial strains on TSAII obtained from clinical and ATCC® strains. Seven simulated clinical nares samples (5 mauve and 2 non-mauve) as well as saline control samples.
Annotation Protocol: Samples were plated on BD BBL™ CHROMagar™ MRSAII media. Four dilutions were prepared for each strain in saline at dilutions of 1 x 10^2, 1-5 x 10^4, and 0 CFU/mL (saline). Conducted at two internal sites (Site 1001 and Site 4002) with two different automated systems.
Key Results:
Combined Growth and Color accuracy percentages, with 95% CI, for various strains and dilutions are consistently high, often 100%. For S. haemolyticus (POS 3441) at 10^3 dilution, Combined Growth and Color were 94.4% (85/90) with 95% CI (87.6%, 97.6%).
Average Mauve CFU Diameter When First Detected:
Study Type: Evaluation of CFU diameter upon first detection.
Sample Size: 857 CFUs evaluated.
Data Source: Digital images of plates with MRSA isolates (3 MRSA isolates × 5 replicates per dilution × 2 dilutions on CHROM MRSAII media) processed in 1-hour increments for 22 hours.
Annotation Protocol: 3 microbiologists measured the diameter of mauve colonies at first detection by the application.
Key Results:
Average Mauve CFU Diameter (mm) When First Detected:
MRSA 1 (ATCC® 43300TM): 0.42 mm (SD 0.12 mm)
MRSA 2 (ATCC® 33591TM): 0.38 mm (SD 0.10 mm)
MRSA 3 (POS3679*): 0.39 mm (SD 0.09 mm)
Clinical Performance Studies:
Study Type: Clinical Study
Sample Size: Approximately 1,800 clinical anterior nares specimens.
Data Source: Clinical anterior nares specimens plated and incubated in air (O2) for 24 hours on BD BBL™ CHROMagar™ MRSA II media, imaged on the BD Kiestra™ Laboratory Automation Solution at three clinical sites.
Annotation Protocol: Images were manually read by trained microbiologists at those sites for "No growth", "Growth - other" (growth without mauve color), and "Growth MRSA Mauve".
Key Results:
Percent Agreement of BD Kiestra™ MRSA App vs. Manual Read:
No Growth Percent Agreement: 75.6% (773/1023)
Non-Mauve Percent Agreement: 84.5% (207/245)
Mauve Percent Agreement: 98.2% (319/325)
Key Metrics
Digital Quality Image Study:
Combined Percent Agreement:
No Growth: 93.1%
Non-Mauve Growth: 98.3%
Mauve Growth: 98.9%
Digital Image Reproducibility:
Combined Percent Agreement:
No Growth: 98.0%
Non-Mauve Growth: 100%
Mauve Growth: 98.9%
Reproducibility (Seeded Samples) - Combined Growth and Color:
N/A (Saline): 99.7% (95% CI: 99.3%, 99.8%)
MRSA STAAUE POS 10575 (10^2, 10^3, 10^4): 100.0% (with respective CIs)
MRSA STAAUE ATCC 43300 (10^2, 10^3, 10^4): 100.0% (with respective CIs)
MRSA STAAUE POS 8161 (10^2, 10^3, 10^4): 100.0% (with respective CIs)
MRSA STAAUE POS 8214 (10^2, 10^3, 10^4): 100.0% (with respective CIs)
MRSA STAAUE POS 9246 (10^2, 10^3, 10^4): 100.0% (with respective CIs)
S. haemolyticus POS 3441 (10^2): 100.0% (93.5%, 100.0%)
S. haemolyticus POS 3441 (10^3): 94.4% (87.6%, 97.6%)
S. haemolyticus POS 3441 (10^4): 100.0% (95.9%, 100.0%)
S. haemolyticus POS 8113 (10^2, 10^3, 10^4): 100.0% (with respective CIs)
Clinical Performance Studies:
No Growth Percent Agreement: 75.6%
Non-Mauve Percent Agreement: 84.5%
Mauve Percent Agreement: 98.2%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2190 Automated image assessment system for microbial colonies on solid culture media.
(a)
Identification. An automated image assessment system for microbial colonies on solid culture media is a system that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, and phenotypic and morphologic characteristics through analysis of two dimensional digital images as an aid in diagnosis of infectious disease.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include a detailed description of the device, including the technology employed, components and software modules, as well as a detailed explanation of the result algorithms and any expert rules that are used to assess colony characteristics and enumerate colonies from image capture through end result.
(2) Premarket notification submissions must include detailed documentation of the analytical studies performed to characterize device performance to support the intended use, as appropriate.
(3) Premarket notification submissions must include detailed documentation from clinical studies performed on a population that is consistent with the intended use population.
(i) The clinical studies must establish the device performance based on comparison to results obtained by an acceptable reference method, as appropriate.
(ii) The clinical study documentation must include the study protocol with a predefined statistical analysis plan and the final report documenting support for the Indications for Use and the results of the statistical analysis, as appropriate.
(4) Premarket notification submissions must include detailed documentation for device software, including but not limited to software applications and hardware based components that incorporate software, and any decision-making thresholds used to generate results for the device. If a part of a Total Laboratory Automation System, the premarket notification submission must include detailed documentation addressing the instrument and software system integration.
(5) Premarket notification submissions must include detailed documentation of appropriate instructions for use regarding the intended user's device quality control procedures for the instrument system and components, as appropriate.
(6) The 21 CFR 809.10 compliant device labeling must include:
(i) Detailed user instructions to mitigate the risk of failure to operate the instrument correctly.
(ii) A detailed explanation of the interpretation of results and limitations regarding the need for review of culture plates by a qualified microbiologist, as appropriate.
(iii) A summary of performance data obtained from the analytical studies used to support device performance, as appropriate.
(iv) A summary of performance data obtained from clinical studies performed on a population that is consistent with the intended use population, as appropriate.
(7) Under 21 CFR 820.30 compliant design control, device manufacturers must, as appropriate:
(i) Conduct human factors/usability validation testing with the final version of the labeling and related materials to adequately mitigate the risk of failure to operate the instrument correctly.
(ii) Document a device training program that will be offered to the end user to adequately mitigate the risk of failure to operate the instrument correctly.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 4, 2023
BD Kiestra B.V. Karin Brands Manager Regulatory Affairs Marconilaan 6 Drachten, Frisia 9207 JC Netherlands
Re: K213280
Trade/Device Name: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App Regulation Number: 21 CFR 866.2190 Regulation Name: Automated Image Assessment System For Microbial Colonies On Solid Culture Media Regulatory Class: Class II Product Code: QQY Dated: September 30, 2021 Received: October 1, 2021
Dear Karin Brands:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213280
Device Name
BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable) □ Over-The Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
3
Image /page/3/Picture/0 description: The image shows the title of a document, which is a 510(k) Summary. The document is an application for the BD Kiestra system for Methicillin-resistant Staphylococcus aureus (MRSA). The BD logo is on the left side of the text.
510(k) Summary Preparation Date: 4 May 2023
Submitted by:
BD Kiestra BV Marconilaan 6 9207 JC Drachten The Netherlands
Contact:
Karin Brands Manager Regulatory Affairs Tel: +31 646 804 924 Email: Karin.brands(@bd.com
Proprietary Names: BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application
Common Names:
BD Kiestra™ MRSA App MRSA App
Regulatory Information
Regulation section: Automated image assessment system for microbial colonies on solid 866.2190 culture media
Classification: Class II
Panel: Microbiology
Product Code(s): QQY
Predicate Device
APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module, Clever Culture Systems AG
Device Establishment
BD Kiestra B.V. Marconilaan 6 9207 JC Drachten, The Netherlands Registration Number: 3010141591
Performance Standards
N/A
4
Image /page/4/Picture/0 description: The image shows the BD logo. The logo consists of an orange circle with a white star-like design inside, followed by the letters "BD" in blue. The star-like design has multiple points radiating from the center of the circle. The letters "BD" are in a bold, sans-serif font.
Intended 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 to screen for 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.
Special Conditions for Use Statement: For prescription use
Special Instrument Requirements: Integrated into the BD Kiestra™ Laboratory Automation Solution
Device Description
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will be optional for the BD Kiestra™ Laboratory Automation Solution and will support laboratory technologists in batching no growth on the BD BBL™ CHROMagar™ MRSA II, growth with no key colony color detected for MRSA ("Growth – other"), and growth with key colony color detected for MRSA ("Growth MRSA Mauve"). These classifications will be characterized as "no growth" and "growth with mauve color" from BD BBLTM CHROMagar™ MRSA II media, from anterior nares samples.
The technologist has the ability to create work lists in BD Synapsys™ informatics solution based on the classifications (growth, no growth or growth with mauve color). These work lists will be used for followup work and batching of results, at the sample level.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will apply Image Algorithms to the digital images to determine if the plate contains "growth" or "no growth". At the individual plate level when the Image Algorithms detects colony growth and potential mauve color the classification will be "growth with mauve color".
When the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is not capable of automatically generating the outputs (visual attributes: growth with or without mauve color/no
5
Image /page/5/Picture/0 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized sunburst symbol in orange and the letters "BD" in blue. The sunburst symbol is on the left, and the letters "BD" are on the right. The letters are in a bold, sans-serif font.
growth), the laboratory technologist will be required to read the digital image of the plate on the computer screen and decide on follow-up action as is the current standard laboratory practice.
Test Principle
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will be used by trained laboratory technologists. Anterior nares specimens will be inoculated manually or automated by use of the BD Kiestra™ InoqulA+TM or the BD Kiestra™ InoqulA, which are part of the BD Kiestra™ Laboratory Automation Solution, onto BD BBLTM CHROMagar™ MRSA II plates.
The BD Kiestra™ InoqulA+™ or BD Kiestra™ Inoculates and streaks the specimen onto the BD BBL™ CHROMagar™ MRSA II plates. The plates are automatically transferred to the BD Kiestra™ ReadA™ Compact or BD Kiestra™ ReadA where they are incubated at 35°C in O2.
Following a short incubation period (typically 1.5 - 3.5 hours), the plate is imaged by the camera onboard the BD Kiestra™ ReadA™ Compact or BD Kiestra™ ReadA, to obtain a baseline image when no significant bacterial growth can be observed. By the 1.5 - 3.5 hours incubation time point, the plate temperature has reached the incubator temperature and condensation under the plate has dissipated, enabling a clear image of the media to serve as the reference image (T0). This T0 image is used as the baseline comparison for all subsequent images taken to ensure artifacts in the image are not considered growth and to evaluate differential contrast from growing colonies. At all timepoints, in order to maximize colony contrast to their background, the images include illumination from the top, side and bottom of the plate using black (top and side illumination) or white (bottom illumination) contrasting background.
The camera resides on the BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA. When an image is scheduled to be taken, the plate is moved to the camera and a digital image is captured. The plate is immediately returned to its designated place, so the plate never leaves the BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA. The plate is aligned each time an image is taken by utilizing the plate barcode for the alignment.
The camera produces raw data, pixel values, which are processed by the Optis Image Software resident on the BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA. The BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA software handles only the mechanical movements within the BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA and interacts with the Image Software. The Image Software analyzes the plate pixel values to determine the optimal image acquisition sequence maximizing the signal to noise ratio and dynamic range. The image is further processed and corrections for chromatic aberrations and geometrical distortions are applied, which creates a high quality and normalized image.
Aside from the T0 baseline image time point (1.5 - 3.5 hours) and intermediate time point (10 - 14 hours), the imaging times are also set for at least one endpoint reading of 20 - 26 hours. Users can configure other time points in the BD Kiestra™ database manager, at the time of installation. Final incubation time is configured by the user based on the plated media formulation and the user's standard operation procedures. The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application compares each image to the corresponding baseline image for comparison for new growth and to rule out artifacts in the media such as dust or air bubbles, see Figure 1.
6
Image /page/6/Picture/0 description: The image shows the text "510(k) Summary BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application". The text is left-aligned and in a sans-serif font. The first line is slightly smaller than the second and third lines.
Baseline image showing artifacts such as ink jet printing, dust and frosted marker Figure 1:
Image /page/6/Picture/2 description: The image shows a petri dish with a clear agar medium. A piece of tape is on the top right of the dish. There is some text on the right side of the dish that says "LOT 5034358 201". The dish is sitting on a black surface.
The time series images are collected for each plate to allow for growth determination and the presence of mauve colored growth by the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application.
Based on these results, growth and mauve, the images can be sorted in order to streamline and optimize the reading workflow. Plates with no growth can be grouped in a batch list where the user can screen the proposed no growth results in a batch and report with one click. Images that show growth without any trace of mauve can be shown in a different list for single or batch evaluation, and the samples that show the presence of the mauve color will be shown in a separate list for review and further work up so that the user can prioritize those cases.
Patient demographics that are provided via the Laboratory Information System (LIS) can be used to further sort the results, through the user of user-defined expert rules.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application supports all features including reporting to the LIS by way of BD Synapsys™ informatics solution.
Substantial Equivalence1
Predicate Device Name: APAS Independence 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 equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or the courts.
7
Image /page/7/Picture/0 description: The image shows the BD logo. On the left is an orange circle with a stylized image of a sun or star inside. To the right of the circle are the letters "BD" in blue. The letters are bold and sans-serif.
Substantial Equivalence Comparison
| | BD KiestraTM Methicillin-resistant
Staphylococcus aureus (MRSA) Application
Subject of this 510(k) | APAS Independence with IC
Chromogenic MRSA BD Analysis
Module; APAS Independence with IC
Chromogenic MRSA TFS/S Analysis
Module
K200839 (Predicate Device) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade
Name | BD KiestraTM Methicillin-resistant
Staphylococcus aureus (MRSA) Application | APAS Independence with IC Chromogenic
MRSA BD Analysis Module; APAS
Independence with IC Chromogenic
MRSA TFS/S Analysis Module |
| | General Device Characteristic Similarities | |
| Intended Use | BD KiestraTM Methicillin-resistant
Staphylococcus aureus (MRSA) Application is an
in vitro diagnostic system comprised of
instruments (BD KiestraTM solution) and a
software application for specific indications that
are used to automate imaging and interpretation
of microbial colonies on plated media | The APAS Independence is in vitro
diagnostic system comprised of an
instrument and software analysis module(s)
for specific indications that are used to
automate imaging and interpretation of
microbial colonies on plates of solid
culture media. |
| Indications for
Use | The BD KiestraTM Methicillin-resistant
Staphylococcus aureus (MRSA) Application is an
in-vitro diagnostic software program that requires
the BD KiestraTM Laboratory Automation
Solution in order to operate.
The BD KiestraTM 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 to
screen for 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 | The APAS Independence 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 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
BBLTM CHROMagarTM MRSA II 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 |
| | BD KiestraTM Methicillin-resistant
Staphylococcus aureus (MRSA) Application
Subject of this 510(k) | APAS Independence with IC
Chromogenic MRSA BD Analysis
Module; APAS Independence with IC
Chromogenic MRSA TFS/S Analysis
Module
K200839 (Predicate Device) |
| | 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 KiestraTM Methicillin-resistant
Staphylococcus aureus (MRSA) Application is
indicated for use in the clinical laboratory. | 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 SpectraTM 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. |
| Imaging Station | BD KiestraTM ReadA and the BD KiestraTM
ReadATM Compact are equipped with the imaging
station using Light Emitting Diode (LED)
illumination of plated media and image capture
using High Speed CMOS Image Sensor camera | Light Emitting Diode (LED) illumination
of culture plates and image capture using a
Charged Coupled Device (CCD) camera |
| Controller PC | BD KiestraTM ReadA and the BD KiestraTM
ReadATM Compact, has its own controller PC that
controls the image capturing and images storing | Control image capture, analysis, report
generation and result storage |
| Analysis Module | On the SCU a virtual server is hosted, on which
amongst others the APP (Plate Image Analyzer
and Plate Algorithm libraries) are running. These
services process the images and meta data for
analysis. These results are sent to BD SynapsysTM
informatics solution
BD SynapsysTM informatics solution is installed
on the BD KiestraTM Solution to provide user
configuration of image visualization and user
configurable workflow rules for imaging result
interpretation. Results are sent to LIS by BD
SynapsysTM informatics solution after being
manually reviewed and released individually or as | Installed on the APAS Controller PC to
provide the configuration and instructions
for image capture and analysis |
| | BD Kiestra™ Methicillin-resistant
Staphylococcus aureus (MRSA) Application
Subject of this 510(k) | APAS Independence with IC
Chromogenic MRSA BD Analysis
Module; APAS Independence with IC
Chromogenic MRSA TFS/S Analysis
Module
K200839 (Predicate Device) |
| | a batch by a trained microbiologist upon review
of the digital plate images | |
| Calibration | In order to keep the camera working optimally, in
both the BD Kiestra™ ReadA and the BD
Kiestra™ ReadA™ Compact, it is necessary for
the user to occasionally calibrate the camera when
alerted to do so and after cleaning. Calibration
needs to be performed with BD provided
calibration plates. | Performed daily using a manufacturer-
provided Color Check Tool |
| Biological
Quality Control | Performed per BD BBL™ CHROMagar™
MRSA II media package insert instructions. | Performed daily using standardized
suspensions of Staphylococcus aureus
ATCC 43300 (MRSA positive strain) |
| General Device Characteristics Differences | | |
| Plate Handling | Automatic | Automated |
| Instrument
Controller PC | Provides the user interface for the BD Kiestra™
Methicillin-resistant Staphylococcus aureus
(MRSA) Application powered by BD Synapsys™
informatics solution | Provides the user interface for the APAS
Independence and controls plate movement |
| Laboratory
Information
System (LIS)
Data import | Data import through BD Synapsys™ informatics
solution | Analysis result for each plate sent to the
LIS. Sample ID details retrieved from the
LIS |
| Result Reporting | Results are sent to LIS by BD Synapsys™
informatics solution after being manually
reviewed and released individually or as a batch
by a trained microbiologist upon review of the
digital plate images. | Consists of software for image analysis and
presentation of reports. When APAS
Independence with IC MRSA
Chromogenic BD analysis module
completes the analysis of each plate, the
APAS-generated result is sent to the LIS |
8
Image /page/8/Picture/0 description: The image shows the BD logo. The logo consists of an orange circle with a white star-like design inside, followed by the letters "BD" in blue. The letters are in a bold, sans-serif font and are slightly spaced apart.
9
Image /page/9/Picture/0 description: The image shows the BD logo. The logo consists of an orange circle with a white design inside, and the letters "BD" in blue. The design inside the circle looks like a stylized sun with rays emanating from the center.
Analytical Performance
Digital Quality Image Study
An internal digital image quality study was performed using simulated surveillance samples including MRSA, non-MRSA, and saline controls to show equivalency between a microbiologist interpreting a digital image and interpreting a plate manually (direct in hand).
Samples were plated on BD BBL™ CHROMagar™ MRSAII agar, incubated, and imaged using the BD Kiestra™ Laboratory Automation Solution. Digital images of the plates were acquired using the BD Kiestra™ ReadA Compact with 5 MP camera. Following image collection, three trained clinical microbiologists evaluated plates manually and from the digital image. Samples were randomized and readers did not have access to the direct plate when reading digital images. Results were categorized as
10
mauve growth, non-mauve growth, or no growth. Manual plate results were compared to the digital image results to calculate overall percent agreement. Further stratification is provided by microbiologist.
Tables 1 - 5 summarize the study results.
Table 1: Spread of Results between Manual Plate Reading and Digital Image Reading
| MANUAL PLATE | |||||
|---|---|---|---|---|---|
| No Growth | Non-Mauve | ||||
| Growth | Mauve | ||||
| Growth | Total | ||||
| DIGITAL IMAGE | No Growth | 148 | 2 | 1 | 151 |
| Non- Mauve | |||||
| Growth | 8 | 169 | 1 | 178 | |
| Mauve Growth | 3 | 1 | 188 | 192 | |
| Total | 159 | 172 | 190 | 521 | |
| Percent Agreement | 148/159 | ||||
| (93.1%) | 169/172 | ||||
| (98.3%) | 188/190 | ||||
| (98.9%) |
Table 2: Microbiologist Manual Plate Reading Result (Percent Agreement) with Digital Image Reading Result
| | No. of
Results | Percent Agreement1 | | |
|------------------|-------------------|--------------------|------------------|-----------------|
| | | No Growth | Non-Mauve Growth | Mauve Growth |
| Microbiologist 1 | 174 | 48/51 (94.1%) | 56/58 (96.6%) | 64/65 (98.5%) |
| Microbiologist 2 | 172 | 49/55 (89.1%) | 55/55 (100%) | 61/62 (98.4%) |
| Microbiologist 3 | 175 | 51/53 (96.2%) | 58/59 (98.3%) | 63/63 (100%) |
| Combined | 521 | 148/159 (93.1%) | 169/172 (98.3%) | 188/190 (98.9%) |
1 Percent agreement determined by dividing number of digital image results by the number of the manual plate read results from the same microbiologist for each designation.
Table 3: Microbiologist 1 Manual Plate Reading Result with Digital Image Reading Result
| Microbiologist 1 | Manual Plate | ||||
|---|---|---|---|---|---|
| No Growth | Non-Mauve Growth | Mauve Growth | Total | ||
| Digital Image | No Growth | 48 | 2 | 0 | 59 |
| Non-Mauve Growth | 3 | 56 | 1 | 60 | |
| Mauve Growth | 0 | 0 | 64 | 64 | |
| Total | 51 | 58 | 65 | 174 | |
| No Growth Agreement: 94.1% (48/51) | |||||
| Non-Mauve growth Agreement: 96.6% (56/58) | |||||
| Mauve growth Agreement: 98.5% (64/65) |
11
| Microbiologist 2 | Manual Plate | ||||
|---|---|---|---|---|---|
| No Growth | Non-Mauve | ||||
| Growth | Mauve Growth | Total | |||
| Digital Image | No Growth | 49 | 0 | 1 | 50 |
| Non-Mauve | |||||
| Growth | 4 | 55 | 0 | 59 | |
| Mauve Growth | 2 | 0 | 61 | 63 | |
| Total | 55 | 55 | 62 | 172 | |
| No Growth Agreement: | 89.1% (49/55) | ||||
| Non-Mauve growth Agreement: | 100.0% (55/55) | ||||
| Mauve growth Agreement: | 98.4% (61/62) |
Table 4: Microbiologist 2 Manual Plate Reading Result with Digital Image Reading Result
Table 5: Microbiologist 3 Manual Plate Reading Result with Digital Image Reading Result
| Microbiologist 3 | Manual Plate | ||||
|---|---|---|---|---|---|
| Digital Image | No Growth | Non-Mauve Growth | Mauve Growth | Total | |
| No Growth | 52 | 0 | 0 | 52 | |
| Non-Mauve Growth | 1 | 58 | 0 | 59 | |
| Mauve Growth | 1 | 1 | 63 | 65 | |
| Total | 53 | 59 | 63 | 175 | |
| No Growth Agreement: | 96.2% (51/53) | ||||
| Non-Mauve growth Agreement: | 98.3% (58/59) | ||||
| Mauve growth Agreement: | 100.0% (63/63) |
Digital Image Reproducibility
Results from the internal digital image quality study (Table 6 - 10) were used to evaluate reproducibility among a panel of microbiologists for the digital image read. Analysis was performed by comparing the microbiologist's interpretation to the final digital image result (determined by 2/3 majority microbiologist result) to calculate percent agreement.
12
| Manual | |||||
|---|---|---|---|---|---|
| No Growth | Non-Mauve Growth | Mauve Growth | Total | ||
| Digital | |||||
| Image | No Growth | 150 | 2 | 1 | 153 |
| Non-Mauve | |||||
| Growth | 0 | 175 | 0 | 175 | |
| Mauve Growth | 1 | 1 | 188 | 190 | |
| Total | 151 | 178 | 189 | 518 | |
| Percent Agreement | |||||
| 150/153 (98.0%) | 175/175 (100%) | 188/190 (98.9%) |
Table 6: Reproducibility of Digital Image Reading Results
Table 7: Microbiologist Reproducibility (Percent Agreement) with Digital Image Reading Result
| | No. of
Results1 | Percent Agreement2 | | |
|------------------|--------------------|--------------------|---------------------|-----------------|
| | | No Growth | Non-Mauve
Growth | Mauve Growth |
| Microbiologist 1 | 173 | 50/51 (98.0%) | 58/58 (100%) | 63/64 (98.4%) |
| Microbiologist 2 | 171 | 49/51 (96.1%) | 58/58 (100%) | 61/62 (98.4%) |
| Microbiologist 3 | 174 | 51/51 (100%) | 59/59 (100%) | 64/64 (100%) |
| Combined | 518 | 150/153 (98.0%) | 175/175 (100%) | 188/190 (98.9%) |
1 Three results were excluded from the reproducibility analysis since results from at least one microbiologist was determined to be invalid. 2 Percent agreement determined by dividial microbiologist digital read results by the number of panel digital image microbiologist results for each designation (i.e., "no growth", "non-mauve growth").
Table 8: Microbiologist 1 Reproducibility of Digital Image Reading Result
| Microbiologist 1 | Manual Read | ||||
|---|---|---|---|---|---|
| No Growth | Non-Mauve Growth | Mauve Growth | Total | ||
| Digital | |||||
| Image | No Growth | 50 | 1 | 0 | 51 |
| Non-Mauve Growth | 0 | 58 | 0 | 58 | |
| Mauve Growth | 0 | 1 | 63 | 64 | |
| Total | 50 | 60 | 63 | 173 | |
| No Growth Agreement: | 98.0% (50/51) | ||||
| Non-Mauve Growth | |||||
| Agreement: | 100% (58/58) | ||||
| Mauve Growth Agreement: | 98.4% (63/64) |
13
| Microbiologist 2 | Manual Read | Total | |||
|---|---|---|---|---|---|
| No Growth | Non-Mauve | ||||
| Growth | Mauve | ||||
| Growth | |||||
| Digital Image | No Growth | 49 | 1 | 1 | 51 |
| Non-Mauve | |||||
| Growth | 0 | 58 | 0 | 58 | |
| Mauve Growth | 1 | 0 | 61 | 62 | |
| Total | 50 | 59 | 62 | 171 | |
| No Growth Agreement: | 96.1% (49/51) | ||||
| Non-Mauve Growth | |||||
| Agreement: | 100% (58/58) | ||||
| Mauve Growth Agreement: | 98.4% (61/62) |
Table 9: Microbiologist 2 Reproducibility of Digital Image Reading Result
Table 10: Microbiologist 3 Reproducibility of Digital Image Reading Result
| Microbiologist 3 | Manual Read | ||||
|---|---|---|---|---|---|
| No | |||||
| Growth | Non-Mauve | ||||
| Growth | Mauve | ||||
| Growth | Total | ||||
| Digital | |||||
| Image | No Growth | 51 | 0 | 0 | 51 |
| Non-Mauve Growth | 0 | 59 | 0 | 59 | |
| Mauve Growth | 0 | 0 | 64 | 64 | |
| Total | 51 | 59 | 64 | 174 | |
| No Growth Agreement: | 100.0% (51/51) | ||||
| Non-Mauve Growth | |||||
| Agreement: | 100.0% (59/59) | ||||
| Mauve Growth Agreement: | 100.0% (64/64) |
Reproducibility
An internal reproducibility study was conducted with seeded samples representing MRSA positive (mauve) and MRSA negative (non-mauve) isolates. Seeded samples were created with saline using 18-24-hour bacterial strains on TSAII obtained from clinical and ATCC® strains. The Reproducibility Study was conducted at two internal sites at the BD Sparks, MD location with two different automated systems. A panel of 7 simulated clinical nares samples (5 mauve and 2 non-mauve) as well as saline control samples (expected no growth) were evaluated including the following:
14
Image /page/14/Picture/0 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized orange sun-like symbol on the left and the letters "BD" in blue on the right. The sun-like symbol has a circle in the center and several rays emanating from it. The letters "BD" are in a bold, sans-serif font.
Mauve
Staphylococcus aureus methicillin resistant (Collection: POS 9246, Source: clinical) Staphylococcus aureus methicillin resistant (Collection: POS 3890, Source: ATCC® 43300™) Staphylococcus aureus methicillin resistant (Collection: POS 8161, Source: clinical) Staphylococcus aureus methicillin resistant (Collection: POS 8214, Source: clinical) Staphylococcus aureus methicillin resistant (Collection: POS 10575, Source: clinical)
Non-Mauve
Staphylococcus haemolyticus (Collection: POS 3441, Source: clinical) Staphylococcus haemolyticus (Collection: POS 8113, Source: clinical)
The samples were plated on BD BBL™ CHROMagar™ MRSAII media. Four dilutions were prepared for each strain in saline at dilutions of 1 × 102, 1-5 × 104, and 0 CFU/mL (saline). The following table shows the results per site and organism:
| Seeded
organism | Dilution | Site 1001
Growth | Site 1001
Color | Site 4002
Growth | Site 4002
Color | Combined
Growth
(95% CI) | Combined
Color
(95% CI) |
|------------------------------|----------|----------------------|----------------------|----------------------|----------------------|----------------------------------------|----------------------------------------|
| N/A (Saline) | 0 | 99.6%
(1029/1033) | 99.6%
(1029/1033) | 99.7%
(1053/1056) | 99.7%
(1053/1056) | 99.7%
(2082/2089)
(99.3%, 99.8%) | 99.7%
(2082/2089)
(99.3%, 99.8%) |
| | 10^2 | 100.0%
(55/55) | 100.0%
(55/55) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(100/100)
(96.3%, 100.0%) | 100.0%
(100/100)
(96.3%, 100.0%) |
| MRSA
STAAUE
POS 10575 | 10^3 | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(90/90)
(95.9%, 100.0%) | 100.0%
(90/90)
(95.9%, 100.0%) |
| | 10^4 | 100.0%
(75/75) | 100.0%
(75/75) | 100.0%
(73/73) | 100.0%
(73/73) | 100.0%
(148/148)
(97.5%, 100.0%) | 100.0%
(148/148)
(97.5%, 100.0%) |
| | 10^2 | 100.0%
(35/35) | 100.0%
(35/35) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(80/80)
(95.4%, 100.0%) | 100.0%
(80/80)
(95.4%, 100.0%) |
| MRSA
STAAUE
ATCC 43300 | 10^3 | 100.0%
(59/59) | 100.0%
(59/59) | 100.0%
(60/60) | 100.0%
(60/60) | 100.0%
(119/119)
(96.9%, 100.0%) | 100.0%
(119/119)
(96.9%, 100.0%) |
| | 10^4 | 100.0%
(60/60) | 100.0%
(60/60) | 100.0%
(55/55) | 100.0%
(55/55) | 100.0%
(115/115)
(96.8%, 100.0%) | 100.0%
(115/115)
(96.8%, 100.0%) |
| MRSA | 10^2 | 100.0%
(60/60) | 100.0%
(60/60) | 100.0%
(59/59) | 100.0%
(59/59) | 100.0%
(119/119)
(96.9%, 100.0%) | 100.0%
(119/119)
(96.9%, 100.0%) |
| STAAUE | 10^3 | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0% (90/90)
(95.9%, 100.0%) | 100.0% (90/90)
(95.9%, 100.0%) |
| POS 8161 | 10^4 | 100.0%
(75/75) | 100.0%
(75/75) | 100.0%
(90/90) | 100.0%
(90/90) | 100.0%
(165/165)
(97.7%, 100.0%) | 100.0%
(165/165)
(97.7%, 100.0%) |
| MRSA
STAAUE
POS 8214 | 10^2 | 100.0%
(50/50) | 100.0%
(50/50) | 100.0%
(35/35) | 100.0%
(35/35) | 100.0%
(85/85)
(95.7%, 100.0%) | 100.0%
(85/85)
(95.7%, 100.0%) |
15
Image /page/15/Picture/0 description: The image shows the BD logo. The logo consists of an orange circle with a white design inside, and the letters "BD" in blue to the right of the circle. The design inside the circle looks like a sun with rays coming out from the center.
| Seeded
organism | Dilution | Site 1001
Growth | Site 1001
Color | Site 4002
Growth | Site 4002
Color | Combined
Growth
(95% CI) | Combined
Color
(95% CI) |
|---------------------------------------|----------|---------------------|--------------------|---------------------|--------------------|----------------------------------------|----------------------------------------|
| | 10^3 | 100.0%
(59/59) | 100.0%
(59/59) | 100.0%
(59/59) | 100.0%
(59/59) | 100.0%
(118/118)
(96.8%, 100.0%) | 100.0%
(118/118)
(96.8%, 100.0%) |
| | 10^4 | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(90/90)
(95.9%, 100.0%) | 100.0%
(90/90)
(95.9%, 100.0%) |
| | 10^2 | 100.0%
(40/40) | 100.0%
(40/40) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(85/85)
(95.7%, 100.0%) | 100.0%
(85/85)
(95.7%, 100.0%) |
| MRSA
STAAUE
POS 9246 | 10^3 | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(90/90)
(95.9%, 100.0%) | 100.0%
(90/90)
(95.9%, 100.0%) |
| | 10^4 | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(90/90)
(95.9%, 100.0%) | 100.0%
(90/90)
(95.9%, 100.0%) |
| | 10^2 | 100.0%
(25/25) | 100.0%
(25/25) | 100.0%
(30/30) | 100.0%
(30/30) | 100.0%
(55/55)
(93.5%, 100.0%) | 100.0%
(55/55)
(93.5%, 100.0%) |
| S. haemolyticus
STAHAE
POS 3441 | 10^3 | 88.9% (40/45) | 88.9% (40/45) | 100.0%
(45/45) | 100.0%
(45/45) | 94.4%
(85/90)
(87.6%, 97.6%) | 94.4%
(85/90)
(87.6%, 97.6%) |
| | 10^4 | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(90/90)
(95.9%, 100.0%) | 100.0%
(90/90)
(95.9%, 100.0%) |
| | 10^2 | 100.0%
(40/40) | 100.0%
(40/40) | 97.8% (40/40) | 97.8% (40/40) | 100.0%
(80/80)
(95.4%, 100.0%) | 100.0%
(80/80)
(95.4%, 100.0%) |
| S. haemolyticus
STAHAE
POS 8113 | 10^3 | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(90/90)
(95.9%, 100.0%) | 100.0%
(90/90)
(95.9%, 100.0%) |
| | 10^4 | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(45/45) | 100.0%
(90/90)
(95.9%, 100.0%) | 100.0%
(90/90)
(95.9%, 100.0%) |
Average Mauve CFU Diameter When First Detected
To determine the average CFU diameter of a mauve colony when first detected, an unlocked version of the application (Not available for commercial use) was used to process digital images of plates with MRSA isolates in 1-hour increments starting at hour 2 and ending at hour 22. These images were then evaluated by 3 microbiologists to measure the diameter of the mauve colonies at first detection by the application. A total of 857 CFUs were evaluated throughout the full 22-hour incubation time.
16
Image /page/16/Picture/0 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized sunburst in orange on the left and the letters "BD" in blue on the right. The sunburst is a circular shape with several triangular rays emanating from the center. The letters "BD" are in a bold, sans-serif font.
Testing included:
- 3 MRSA isolates × 5 replicates per dilution × 2 dilutions ●
- 1 media type (BD BBL™ CHROMagar™ MRSAII media) evaluated ●
- total of 30 plates evaluated using images collected every hour from 2-22 hours of incubation (30 plates × 21 images per plate = approximately 630 images)
The following table shows the average mauve CFU diameter when first detected:
| Strain
name | Reference
Number | BD Test
Media | Tracked
CFU count | Average Mauve CFU Diameter
(mm) When First Detected | Mauve CFU Diameter When
First Detected Standard
Deviation (mm) |
|----------------|---------------------|------------------|----------------------|--------------------------------------------------------|----------------------------------------------------------------------|
| MRSA 1 | ATCC® 43300TM | CHROM
MRSAII | 277 | 0.42 | 0.12 |
| MRSA 2 | ATCC® 33591TM | CHROM
MRSAII | 236 | 0.38 | 0.10 |
| MRSA 3 | POS3679* | CHROM
MRSAII | 344 | 0.39 | 0.09 |
*Internal reference number
Clinical Performance Studies
Approximately 1,800 clinical anterior nares specimens were plated, incubated, and imaged on the BD Kiestra™ Laboratory Automation Solution at three clinical sites. To establish performance of the MRSA app, the images were manually read by trained microbiologists at those sites for the following requirements:
- "No growth" .
- . "Growth - other" (growth without mauve color)
- "Growth MRSA Mauve"
Clinical anterior nares specimens were plated and incubated in air (O2) for 24 hours on BD BBL™ CHROMagar™ MRSA II media. The Percent Agreement for each interpretation are listed in the following table:
| | | No Growth | Non-Mauve
Growth | Mauve Growth | Grand Total |
|------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------|---------------------|--------------|-------------|
| BD KiestraTM
MRSA App | No Growth | 773 | 9 | 1 | 784 |
| | Non-Mauve
Growth | 237 | 207 | 5 | 456 |
| | Mauve Growth | 13 | 29 | 319 | 369 |
| | Grand Total | 1023 | 245 | 325 | 1593 |
| No Growth Percent Agreement 75.6% (773/1023)
Non-Mauve Percent Agreement: 84.5% (207/245)
Mauve Percent Agreement: 98.2% (319/325) | | | | | |