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The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper System (CA, sirius CA, or sirius one CA) for the qualitative identification of microorganisms using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens. The BD Kiestra IdentifA is indicated for use in the clinical laboratory with the BD Kiestra ReadA Compact and Bruker MALDI Biotyper System (CA, sirius one CA) to aid in the diagnosis of bacterial and fungal infections.

The BD Kiestra™ IdentifA automates preparation of MALDI targets for the Bruker MALDI Biotyper® CA System, sirius CA system, and/or sirius one CA System that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/lonization Time-of-Flight Mass Spectrometry (MALDI-TOF MS). The system comprises of the BD Kiestra™ IdentifA module (including the associated software and onboard nephelometers and pipetting system), formic acid and automation-compatible transfer vials (for HCCA matrix and Bacterial Test Standard (BTS), which are obtained directly from Bruker and manually transferred to the vials for use on the instrument), consumables (pipette tips and cuvette arrays for preparation of organism suspensions and fluid movement), and nephelometer calibration standards (McFarland standard vials for measuring turbidity of microbial suspensions). When identification of an organism growing on a culture medium plate is required, a technologist designates specific colonies for picking by the BD Kiestra™ IdentifA module using a digital image of the plate obtained using the BD Kiestra™ ReadA Compact module. The BD Kiestra™ IdentifA automatically suspends the designated colonized water and uses an onboard nephelometer to determine the resulting turbidity. The organism concentration is adjusted automatically by picking additional designated colonies or by appropriate dilution of the suspension to achieve a turbidity within a targeted range of McFarland values. Based on the final organism concentration, the BD Kiestra™ IdentifA pipets one or more aliquots of the microbial suspension onto a MALDI target (either reusable 48-spot or disposable 96-spot targets) and dries the spots at elevated temperature. The BD Kiestra™ IdentifA performs the extended Direct Transfer (eDT) Sample Preparation Procedure from Bruker whereby the instrument overlays the dried sample spot on the MALDI target with formic acid and matrix. The BD Kiestra™ IdentifA also spots the BTS used for quality control of MALDI-TOF MS organism identification. Once spots are dry, the technologist manually removes the target from the BD Kiestra™ IdentifA and loads it into the Bruker MALDI Biotyper® System for analysis. Information regarding the location of each sample and BTS on the targets and the associated MALDI-TOF MS results are transmitted between the BD Kiestra™ IdentifA and Bruker MALDI Biotyper® System via the Synapsys Informatics, the main software interface, and the BD Kiestra™ BeA, the data interface hub module that communicates with all the other modules including the BD Kiestra™ IdentifA. In addition to preparing the MALDI target, if requested, the BD Kiestra™ IdentifA will also dilute the organism suspension to a standardized turbidity of 0.5 McFarland. Modules of the BD Kiestra™ System each have their own operating software that communicates via the central BeA data interface hub module with the Synapsys user interface which in turn sends and receives information to/from the Laboratory Information System (LIS). The BD KiestraTM ReadA or ReadA Compact module is required for use in conjunction with the BD Kiestra™ IdentifA module for image capture. Culture plate incubation may be done offline and then moved to the BD Kiestra™ ReadA or ReadA Compact module for imaging, or incubation can be done in the ReadA and then remain in the ReadA for imaging. Additional software modules (BD Synapsys Informatics and BD Kiestra™ BeA) are also required for the function of the BD Kiestra™ IdentifA, and these modules reside on the BD Kiestra™ Laboratory Automation Solution. The digital image is used by the BD Kiestra™ IdentifA for image analysis and colony designation by the operator.

The Colibri™ is an automated in vitro diagnostic specimen preparation system for use with WASPLab® to prepare MALDI-TOF targets for the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media. The Colibri™ is an automated pre-analytical processor that nicks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/lonization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment. The Collori™ software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers. Bacterial suspensions for AST and purity plates are identified by barcode label. The Colibri™ is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bacterial infections. The Colibri™ has not been validated for use in the identification or processing of yeast species, or mycobacteria.

The Colibrí is an instrument which automates the picking of selected colonies from plated media and prepares MALDI target slides for the bioMérieux VITEK MS or the Bruker MALDI Biotyper CA System that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/Tonization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The Colibrí automates the preparation of microbial suspensions at known concentration for bioMérieux VITEK 2 System that is used in clinical laboratories for AST analyses. Moreover, the Colibrí is used for Purity Plates preparation for purity assessments. The Colibrí includes the following components: - . Colibrí instrument and software with on-board pipetting system and nephelometer - Colibrí Primary Tubes ● - . Colibrí Spreader - Colibrí Daily Verification kit. ● Colibri is designed to be used in conjunction with the WASPLab device for culture plate incubation and image analysis. After appropriate plate incubation, the operator selects the colonies from a digital image of culture media plate streaked with microbiological human specimen, available through WebApp software, the WASPLab User Interface. The operator assigns the automatic ID or AST tasks to the isolated colonies to be processed. Then, the operator loads the plates in the Colibri where colonies are automatically picked, spotted on the target slide and overlayed with the matrix or suspended into the dedicated solution for the preparation of the microbial suspension for AST purposes (Secondary Tube). When used in conjunction with the bioMérieux VITEK MS, the Colibrí can prepare the 48-spot target slides by performing the direct spotting of colonies. The calibrator used for quality control is manually applied by the operator at the end of the automated colony spotting. When used in conjunction with the Bruker MALDI Biotyper CA System, the Colibri can prepare either reusable 48-spot or disposable 96-spot targets by performing the Direct Transfer Sample Procedure. The BTS used for quality control is manually applied by the operator at the end of the automated colony spotting. When used in conjunction with the bioMérieux VITEK 2, the Colibrí can prepare the microbial suspension at the proper concentration by direct colony suspension method. The onboard nephelometer allows the preparation of Secondary Tubes (AST suspensions) at the correct concentration and the Colibrí Spreader is used for Purity Plates preparation. The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers. The traceability of prepared Secondary Tube and Purity Plates is maintained by dedicated labels applications. Colibrí requires four different calibrations, one on the nephelometer, three on the cameras. None of these calibration activities require user intervention if not in terms of periodical cleaning of the mechanical component as described in the dedicated section of the User Manual. The Set-up calibration of nephelometer and camera units are performed during the device initial setup. Autocalibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that all the mechanical references can be found inside the positioning tolerances, that the I/Os are responsive. Run-time calibration is performed during the normal usage to automatically check the proper functioning of the Colibrí. Colibrí requires a daily nephelometer verification to check the proper reading of suspensions at different turbidity values.

The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Collbrí Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative bacterial species grown on solid culture media. The Collbri System is a semi-automated pre-analytical processor that picks isolated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibri software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzer. The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory finding Gram staining, to aid in the diagnosis of bacterial infections. The Colibrí System has not been validated for use in identification of yeast species.

The Copan Colibrí System is designed to be used as an accessory of the downstream MALDI-TOF analyzers automating various manual steps in the workflow for the preparation of samples for the identification of isolated colonies of microorganisms cultured from the human body. The Colibrí System automates the preparation of MALDI target slides for the bioMérieux VITEK MS or the Bruker MALDI Biotyper CA System that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/Ionization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The system comprises the Colibrí Vision System and Colibrí Preparation Station and pipette tips as consumables. After appropriate plate incubation, the operator using the graphical User Interface (Image Reading Interface) chooses the plates exhibiting adequate growth and selects the isolated colonies to be processed assigning the automatic ID tasks. By using the Collbrí Vision System, specific colonies to be picked are designated by the operator on a digital plate. The Operator manually loads the plates in the Colibri Preparation Station where colonies are automatically picked, spotted on the target slide and overlayed with the matrix. When used in conjunction with the bioMérieux VITEK MS, the Colibrí System can prepare the 48spot target slides by performing the direct spotting of colonies. The calibrator used for quality control is manually applied by the operator at the end of the automated colony spotting. When used in conjunction with the Bruker MALDI Biotyper CA System, the Colibrí System can prepare either reusable 48-spot or disposable 96-spot targets by performing the Direct Transfer Sample Procedure. The BTS used for quality control is manually applied by the operator at the and of the automated colony spotting. The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers. Colibri System requires three different calibrations. None of these calibration activities require user intervention if not in terms of periodical cleaning of the mechanical component as described in the dedicated section of the User Manual. Set-up calibration is performed during the device initial setup for the camera units positioned on the Colibrí Vision System and on the Colibrí Preparation Station. Auto-calibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that, in the Colibri Preparation Station, all the mechanical references can be found inside the positioning tolerances, that the I/Os are responsive. Run-time calibration is performed during the normal usage to automatically check the proper functioning of the Colibrí Vision System and the Colibri Preparation Station.

The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper CA System for the qualitative identification and differentiation of microorganisms using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens. The BD Kiestra IdentifA is indicated for use in the clinical laboratory with the BD Kiestra Read Compact and Bruker MALDI Biotyper CA System to aid in the diagnosis of bacterial and fungal infections.

The BD Kiestra™ IdentifA is an instrument which automates picking of technologist-selected colonies from plated media and prepares a Bruker MALDI target for identification and differentiation of organisms. The BD Kiestra IdentifA includes the following components (Note: Bruker MALDI targets, Matrix and Bacterial Test Standard (BTS) are required, however, they are obtained directly from Bruker Daltonik GmbH): - . BD Kiestra IdentifA instrument and software with onboard pipetting and nephelometry. - . BD formic acid, deionized water, pipet tips, Matrix and BTS transfer vials. - . BD Kiestra IdentifA nephelometer calibration standards (0.2, 0.5, 1.0 and 3.0 McFarland). - BD Kiestra IdentifA cuvette array. When a MALDI identification is ordered by a technologist selects the colonies from an image of a plated medium obtained using the BD Kiestra™ ReadA Compact. The coordinates of the colonies and the plated medium are transferred to BD Kiestra IdentifA where the colonies are picked. The colonies are suspended in deionized water and the onboard nephelometer determines the McFarland turbidity. Based on the McFarland, BD Kiestra IdentifA pipets the organism suspension onto a Bruker MALDI target. The BD Kiestra IdentifA uses the Bruker extended Direct Transfer method for preparation of the MALDI target by overlaying formic acid and Bruker Matrix onto the target spot. In addition, BTS spots are prepared on the target slide for quality control. Once dried, the technologist manually removes the target and loads onto the Bruker MALDI Biotyper CA System. The BD Kiestra IdentifA transfers the location of sample and BTS spots to the MALDI Biotyper CA. If requested by the technologist, BD Kiestra IdentifA will also dilute the organism suspension to a target of 0.5 McFarland. The BD Kiestra IdentifA can be used as a standalone instrument or integrated into the BD Kiestra Laboratory Automation System. The standalone instrument utilizes an input/output module for manual plate loading, which handles de-stacking and stacking of plates. When physically integrated into the BD Kiestra Laboratory Automation System, BD Kiestra IdentifA is connected to a track by way of a connection module for automatic plate transfer. BD Kiestra IdentifA software is responsible for the instrument functionality and a touchscreen is mounted on the instrument for user interface.