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The Accelerate Arc system is an automated sample preparation device that uses lysis and centrifugation to prepare concentrated microbial suspensions from positive blood culture samples that can be used for bacterial and yeast identification with the Bruker MALDI Biotyper CA System (MBT-CA System) with MBT-CA Sepsityper software extension. Samples are processed directly from BD BACTEC blood culture bottles identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial by Gram stain. The Accelerate Arc system is an in vitro diagnostic device comprised of the Accelerate Arc system software, and the Accelerate Arc BC kit. The Accelerate Arc BC kit is a disposable consumable that includes reagents to concentrate and purify microbial cells from positive blood culture samples. Microbial suspensions prepared by the Accelerate Arc system can be used to identify bacterial species and yeasts in accordance with the Bruker MBT-CA reference library. Subculture of positive blood culture is necessary to recover organisms not identified by the Bruker with MBT-CA Sepsityper software extension, species not indicated for testing with the Bruker MBT-CA System with MBT-CA Sepsityper software extension, for susceptibility testing, and for differentiation/recovery of organisms present in polymicrobial samples. The Accelerate Arc system 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 bloodstream infections.

The Accelerate Arc system is an automated sample preparation device with associated consumables that uses lysis and centrifugation to prepare microbial suspensions from positive blood culture (PBC) samples from BD BACTEC™ bottles that have rung positive on a continuous monitoring system and confirmed to be monomicrobial by Gram stain. Suspensions containing concentrated, monomicrobial microorganisms are intended for use with the downstream mass spectrometry (MS) analyzer Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension for qualitative identification and differentiation of microorganisms to aid in the early diagnosis of bacterial and yeast infections. This device is comprised of an automated sample preparation instrument (Accelerate Arc instrument), system software (Accelerate Arc system software), and sample preparation kit (Accelerate Arc BC kit). The Accelerate Arc system was designed to standardize workflow to minimize operator error and variability. The Accelerate Arc instrument, system software and BC kit rapidly clean up and concentrate microorganisms from positive blood culture samples for downstream identification of the microorganism using the Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension. The confidence score range from the MBT-CA Sepsityper® software extension is used to denote high confidence (1.8 to 3), low confidence (1.6 to 1.79), and no identification (0 to 1.59). Altogether, rapid microorganism identification direct from PBC can be achieved in about 1 ½ hours following this workflow. The maximum system configuration of eight Accelerate Arc modules can process greater than 150 PBCs in a single day. The Accelerate ArcTM system is comprised of: . Accelerate Arc™ instrument Accelerate Arc™ system software . . Accelerate Arc™ BC kit Samples prepared by the Accelerate Arc system are intended for use with: Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software . extension

The MBT Sepsityper is a qualitative in vitro diagnostic device consisting of a MBT-CA (Sepsityper) software extension and a reagent kit (MBT Sepsityper Kit US IVD) for use in conjunction with other clinical and laboratory findings to aid in the early diagnosis of bacterial and yeast infections from positively flagged blood cultures using the MALDI Biotyper CA System. The MBT Sepsityper Kit US IVD is a disposable blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed to demonstrate the presence of a single organism as determined by Gram stain. This sample preparation manual method is performed by laboratory health a clinical diagnostic setting. Subculturing of positive blood cultures is necessary to recover organisms for identification of organisms not identified by the MBT-CA System, for susceptibility testing and for differentiation of mixed growth. Positive MBT Sepsityper results do not rule out co-infection with organisms that may not be detected by the MBT-CA System. Results of the MBT Sepsityper should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Results of the MBT Sepsityper should be correlated with Gram stain results and used in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast bloodstream infections.

The MBT Sepsityper is a qualitative in vitro diagnostic device consisting of a MBT-CA (Sepsityper) software extension and a reagent kit (MBT Sepsityper Kit US IVD). The MBT Sepsityper Kit US IVD is a disposable blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed to demonstrate the presence of a single organism as determined by Gram stain. This sample preparation manual method is performed by laboratory health a clinical diagnostic setting.