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Intended Use: The ASTar System is intended to be used for the automated quantitative susceptibility testing for most clinically significant microorganisms. The ASTar System does not provide organism identification. Indications for Use: The ASTar System, comprised of the ASTar Instrument with the ASTar BC G- Kit (ASTar BC G- Consumable kit, ASTar BC G- Frozen insert, and ASTar BC G-Kit software), utilizes high-speed, time-lapse microscopy imaging of bacteria for the in vitro, quantitative determination of antimicrobial susceptibility of on-panel gram-negative bacteria. The test is performed directly on positive blood culture samples signaled as positive by a continuous monitoring blood culture system and confirmed to contain gram-negative bacilli by Gram stain. Organism identification is required for AST result interpretation and reporting. Test results from the ASTar BC G- Kit should be interpreted in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing. Sub-culturing is necessary to support further testing for: bacteria and antimicrobials not on the ASTar BC G- panel, where inconclusive results are obtained, epidemiologic testing, recovery of organisms present in microbial samples, and susceptibility testing of bacteria in polymicrobial samples. The ASTar BC G- Kit tests the following antimicrobial agents with the following bacterial species: Amikacin: Citrobacter freundii, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens Ampicillin: Escherichia coli, Proteus mirabilis Ampicillin-sulbactam: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris Aztreonam: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Cefazolin: Klebsiella pneumoniae Cefepime: Citrobacter freundii, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Ceftazidime: Enterobacter cloacae complex, Escherichia oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Ceftazidime-avibactam: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens Cefuroxime: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis Ciprofloxacin: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Gentamicin: Citrobacter freundii, Citrobacter koseri, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Levofloxacin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Meropenem: Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Meropenem-vaborbactam: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens Piperacillin-tazobactam: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Tigecycline: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Serratia marcescens Tobramycin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens Trimethoprim-sulfamethoxazole: Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris

ASTar System is a fully automated system for antimicrobial susceptibility testing (AST). It consists of the ASTar Instrument which is used in combination with dedicated application kits. The ASTar BC G- Kit consists of the ASTar BC G- Consumable kit, ASTar BC G- Frozen insert, and ASTar BC G-Kit software which must be installed on the instrument to process the kit. The system provides robust and consistent inoculum preparation for AST and utilizes high-speed, time-lapse microscopy imaging of pathogens in broth microdilution to determine minimum inhibitory concentration (MIC) and qualitative susceptibility results. Organism identification using an approved method is required to be entered into the ASTar Instrument for results to be reported. The instrument is designed to carry out sample preparation of up to six samples in parallel, using a dedicated ASTar Cartridge consumable for each sample. In the subsequent AST culturing step, the instrument transfers the prepared sample into a second dedicated consumable, referred to as the ASTar Disc. Up to 12 Discs can be incubated simultaneously in the system. The processed samples can be in different stages of the processing protocol. New samples can be loaded in a random-access manner when there are available slots. Processing of loaded samples will, in most cases, start shortly after loading. If six samples are started at the same time limitations given by the sample scheduler will result in a queue. The operator interacts with the instrument via the touchscreen display by which the operator controls the instrument. ASTar BC G- Kit is used for in vitro determination of antimicrobial susceptibility testing of commonly isolated bacteria derived from positive blood culture samples confirmed positive for Gram-negative bacteria by Gram stain. The antimicrobial and organism combinations are listed in Table 1. Reportable ranges for each antimicrobial are listed in Table 2. To start an analysis approximately 1 mL of a positive blood culture, confirmed Gram-negative by Gram stain is pipetted into the ASTar Cartridge by the operator and loaded into the system, from which the system purifies and quantifies the bacterial concentration is adjusted to the appropriate inoculum concentration and produces an inoculum for analysis of non-fastidious organisms. The bacterial suspensions are transferred automatically to the ASTar Disc and antimicrobial susceptibility testing is performed based on a defined short-term protocol. Results are available within approximately six hours. Bacterial growth and response to relevant concentrations of different antimicrobial drugs are measured throughout the incubation period, using a high-performance optical detection system in combination with image analysis algorithms. The system generates an MIC and further qualitative susceptibility results (i.e., S, I, R) for the tested antimicrobials when applicable. The qualitative results are determined based on established breakpoints stipulated by applicable authorities, i.e., FDA, CLSI or EUCAST. FDA Susceptibility Testing Interpretive Criteria (STIC), aka "breakpoints" are found in Table 3.