(59 days)
For in vitro diagnostic use:
Etest is a quantitative technique for the 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, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.
This Etest 510(k) application is for MIC determination of Tetracycline in the range of 0.016 - 256 µg/ml with non-fastidious Gram positive and Gram negative aerobic bacteria, H. influenzae, N. gonorrhoeae and Streptococcus spp.
Not Found
Here's an analysis of the provided text regarding the Etest® Tetracycline device, extracting information relevant to acceptance criteria and the supporting study, while noting what information is not present in these specific documents.
It's important to understand that the provided text is an FDA 510(k) clearance letter and an "Indications For Use" statement. These documents do not typically contain detailed study designs, acceptance criteria tables, or comprehensive performance data. They refer to a study that was submitted to the FDA, but the details of that study are not explicitly included here.
Therefore, many of your requested points will be answered as "Not explicitly stated in the provided text."
Acceptance Criteria and Device Performance Study Information for Etest® Tetracycline
Given the provided text, a comprehensive description of acceptance criteria and the full study results is not available. The documents are an FDA clearance letter and the "Indications For Use" statement, which refer to a study that was submitted as part of the 510(k) application (K981134). The specific details of that study are not included in these excerpts.
However, based on the information provided, we can infer some aspects and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/Expected for MIC devices) | Reported Device Performance (Not explicitly stated in provided document) |
|---|---|
| Essential Agreement (EA) with reference method | Not explicitly stated. Typically, a high percentage (e.g., >90-95%) of results should be within ±1 doubling dilution of the reference method MIC. |
| Category Agreement (CA) with reference method | Not explicitly stated. Typically, a high percentage (e.g., >90-95%) of results should have the same susceptibility category (Susceptible, Intermediate, Resistant) as the reference method. |
| Major Discrepancies (MD) rate | *Not explicitly stated. MDs (Resistant by test, Susceptible by reference) should be low (e.g., |
§ 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).