(193 days)
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.
This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 µg/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent.
Active in vitro and in clinical infections
Skin Infections ·
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
Etest is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae. Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes. N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.
This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 ug/mL to the Etest® products.
Here's a breakdown of the acceptance criteria and the study details for the Etest® Ceftaroline device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA Guidance Document: Antimicrobial Susceptibility Test (AST) Systems) | Reported Device Performance (Etest® Ceftaroline) |
|---|---|
| Overall Essential Agreement (EA) | 99.8% |
| Overall Category Agreement (CA) | 99.8% |
| Reproducibility | Acceptable results (details in submission) |
| Quality Control | Acceptable results (details in submission) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size of Test Set: The document states that an "external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains" for Staphylococcus aureus. However, the exact number of isolates used in this test set is not explicitly provided in the given text. It mentions "most strains of the microorganism listed below," but not a specific count for the evaluation.
- Data Provenance: The document implies the data is prospective as it describes an "external evaluation was conducted." The country of origin is not specified, but the submitter (bioMérieux, Inc.) is based in Hazelwood, MO, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not provide information on the number of experts used or their qualifications to establish the ground truth for the test set.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method. The performance is compared directly against the CLSI broth microdilution reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted as per the provided information. This device is an automated in vitro diagnostic test, not a system that assists human readers in interpreting images or data.
6. Standalone Performance:
- Yes, a standalone performance evaluation was conducted. The Etest® Ceftaroline's performance (99.8% EA and 99.8% CA) was compared directly against the CLSI broth microdilution reference method, indicating its performance as an algorithm-only (device-only) system.
7. Type of Ground Truth Used:
- The ground truth used was the CLSI broth microdilution reference method. This is a recognized standard for determining antimicrobial susceptibility.
8. Sample Size for the Training Set:
- The document does not explicitly mention a training set or its sample size. This type of device (antimicrobial susceptibility test) typically relies on biochemical principles and established reference methods rather than a machine learning model that requires a discrete training phase. The "external evaluation" serves as a validation or test set against a known standard.
9. How the Ground Truth for the Training Set was Established:
- As a training set is not explicitly mentioned or implied for this type of device, the method for establishing its ground truth is not applicable based on the provided text. The device's performance is validated against a pre-established reference method.
§ 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).