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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.

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.

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 of colonies with colors suggestive of methicillin-resistant Staphylococcus aureus (MRSA) growth on Beckton Dickinson BBL™ CHROMagar™ 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 plate imaging and interpretation to detect the presence of colonies with colors suggestive of methicillin-resistant Staphylococus 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.

APAS Independence is a device designed to be used in a microbiology laboratory to automate the initial screening of specimens for the presence of growth on culture plates. It is an in vitro diagnostic device and has no direct contact with patients. The APAS Independence consists of an automated plate handling mechanism to move culture plates through the instrument, an imaging station to capture images of culture plates, and software for image analysis (e.g., determination of growth) and presentation of reports. The APAS Independence is intended to be installed with multiple software (analysis) modules, each of which will provide an assessment of growth for a specific clinical indication. More than one analysis module may be developed for the same indication to allow APAS to assess growth on culture plates from multiple agar manufacturers sold for the same indications. This submission includes two MRSA analysis modules that have been developed for the same indication, which is to be used in a microbiology laboratory to automate the initial screening for the presence of presumptive methicillin-resistant Staphylococcus aureus (MRSA) growth on culture plates. It is indicated for the screening of MRSA colonization from swabs, where a specimen is collected from the anterior nares by non-invasive sampling techniques and plated onto specified chromogenic MRSA agars. No quantification of growth is required. APAS Independence with IC MRSA Chromogenic BD Analysis Module is designed to interpret growth on BBL™ CHROMagar™ MRSA II agar from Becton Dickinson, and APAS Independence with IC MRSA Chromogenic TFS/S Analysis Module is designed to interpret growth on Spectra™ MRSA agar from Thermo Fisher Scientific (Remel).