(58 days)
ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minibitory Concentration (MC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media using overnight incubation.
Eravacycline has been shown to be active against most isolates of the microorganisms listed below according to this antimicrobial agent.
ETEST® ERV can be used to determine the MIC of Eravacycline against the following microorganisms:
Active both in vitro and in clinical infections:
Gram-negative:
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
Gram-positive: Enterococcus faecalis Enterococcus faecium
In vitro data are available for the following microorganisms, but clinical significance is unknown:
Citrobacter koseri Klebsiella aerogenes
ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
ETEST® Eravacycline contains a range of eravacycline from 0.002 to 32 µg/mL.
The document describes the performance of the ETEST Eravacycline (ERV) (0.002-32 ug/mL) device for determining the minimum inhibitory concentration (MIC) of Eravacycline against various microorganisms.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Antimicrobial Susceptibility Test (AST) Systems are typically defined by regulatory guidance documents, such as the FDA Class II Special Controls Guidance Document and CLSI standards. For this device, the performance is evaluated based on Essential Agreement (EA) and Category Agreement (CA) with a reference method. While explicit numerical acceptance criteria for EA and CA are not directly stated as pass/fail thresholds in the provided text, the document implies that the reported percentages of EA and CA demonstrate "acceptable performance" and "substantially equivalent performance" when compared to the CLSI reference method and predicate device.
| Performance Metric | Acceptance Criteria (Implied by FDA & CLSI Guidelines) | Reported Device Performance (ETEST® Eravacycline) |
|---|---|---|
| Essential Agreement (EA) | High percentage (typically >90-95%) | Enterobacteriaceae: 99.4% |
| E. faecalis and E. faecium: 100% | ||
| Category Agreement (CA) | High percentage (typically >90-95%) | Enterobacteriaceae: 98.0% |
| E. faecalis and E. faecium: 94.9% | ||
| Reproducibility | High percentage (typically >95%) | Best-case: 99.3%, Worst-case: 99.3% |
| Quality Control | Results within range >95% of the times tested | Results within range >95% of the times tested |
| Overall Very Major Error Rate (Enterobacteriaceae) |
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).