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510(k) Data Aggregation
(87 days)
The MTS (MIC Test Strip) Aztreonam-Avibactam 0.016/4-256/4 μg/mL is a quantitative method intended for in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a predefined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Aztreonam-Avibactam at concentrations of 0.016/4-256/4 μg/mL should be interpreted at 16-20 hours of incubation.
Testing with MTS Aztreonam-Avibactam at concentrations of 0.016/4-256/4 μg/mL is indicated for Enterobacterales as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
The MTS Aztreonam-Avibactam 0.016/4-256/4 μg/mL has demonstrated acceptable performance with the following organisms:
Enterobacterales (Citrobacter freundii complex, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, and Serratia marcescens)
MTS Aztreonam-Avibactam 0.016/4-256/4 μg/mL is made of special high-quality paper impregnated with a predefined concentration of gradient aztreonam across 15 two-fold dilutions like those of a conventional MIC method and avibactam at a fixed concentration of 4 μg/mL. One side of the strip is labeled with the aztreonam-avibactam code (AZA) and the MIC reading scale in μg/mL. When the MTS is applied onto an inoculated agar surface, the performed exponential gradient of antimicrobial agent diffuses into the agar for over an hour. After 16-20 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of μg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. The MIC Test Strip (MTS) is single use only.
Aztreonam-avibactam is the combination of aztreonam (a monobactam) that interferes with bacterial cell wall synthesis and avibactam (a β-lactamase inhibitor) that neutralizes β-lactamase enzymes. It is used in combination with metronidazole to treat complicated intra-abdominal infections (cIAI) caused by susceptible E. coli, K. pneumoniae, K. oxytoca, E. cloacae complex, C. freundii complex and S. marcescens.
MTS is supplied in 3 different packaging options (no additional reagents are included). There is a 10- test box, a 30- test box and a 100-test box.
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