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The LifeScale AST system is a multiplexed in vitro diagnostic test that uses a microfluidic sensor and resonant frequency to calculate organism concentration and/or mass distribution for quantitative antimicrobial susceptibility testing (AST). Testing is performed directly on blood cultures signaled as positive by a continuous monitoring blood culture system and confirmed by Gram stain. The LifeScale AST system does not provide organism identification and is not indicated for use with polymicrobial samples. Interpretive results (Susceptible/Intermediate/Susceptible-dose dependent/Resistant) are provided for specific drug/organism combinations. Results are intended to be used 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 as needed. Additionally, subculture of positive blood culture is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device and for epidemiologic testing and for recovery of organisms present in microbial samples. The LifeScale Gram Negative Kit (LSGN) is intended for use with the LifeScale AST system for in vitro testing of positive blood culture samples confirmed by Gram stain as containing gram-negative bacilli for the antimicrobial agents and specific target organisms identified below: 1. Ampicillin: Escherichia coli 2. Aztreonam: Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca 3. Cefazolin: Escherichia coli, Klebsiella pneumoniae, Klebsiella variicola 4. Ceftazidime: Acinetobacter spp. (other than Acinetobacter ursingii), Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola, Klebsiella pneumoniae, Pseudomonas aeruginosa 5. Ertapenem: Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Klebsiella oxytoca 6. Trimethoprim-Sulfamethoxazole: Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola 7. Amikacin: Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola, Pseudomonas aeruqinosa 8. Cefepime: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa 9. Ceftazidime-avibactam: Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca 10. Gentamicin: Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola, Pseudomonas aeruginosa 11. Levofloxacin: Escherichia coli, Klebsiella pneumoniae, Klebsiella derogenes, Klebsiella oxytoca, Pseudomonas aeruginosa 12. Meropenem: Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa 13. Meropenem-vaborbactam: Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca 14. Piperacillin-tazobactam: Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa

The Affinity Biosensors LifeScale Gram Negative Kit (LSGN) is a semi-automated instrument system for antimicrobial susceptibility testing (AST) directly from positive blood cultures for which the Gram stain shows gram-negative bacilli. The system uses a microfluidic sensor that detects organisms in suspension and measures differences in cell mass between bacterial suspensions incubated in the presence and absence of antibiotic. Minimum inhibitory concentrations (MICs) are determined from data obtained during sample measurement including organism concentration and/or cell mass distributions of individual organisms. The system automatically interprets the measurements to determine MIC values and interpretive results (susceptible, intermediate, or resistant) based on FDA-defined or recognized breakpoints. The organism identification determined using a platform FDA-cleared for use with positive blood culture samples is entered by the user. If the organism identification has not been entered or if the sample has not been confirmed as monomicrobial, the system provides a preliminary report that indicates that organism identification or monomicrobial status is pending. The device Instructions for Use indicates that the preliminary laboratory report should not be reported to the healthcare provider. The final report is provided to the healthcare provider when the organism identification is entered into the system and the culture is confirmed to be monomicrobial samples should not be tested with the LifeScale LSGN Kit. Preliminary results are available in most cases within four hours from initiation of the assay.