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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 µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This Etest 510(k) application is for MIC determination of Trimethoprim/Sulphamethoxazole (1/19) in the range of 0.002 - 32 µg/ml with S. pneumoniae.

Previously cleared applications for Trimethoprim/Sulphamethoxazole (1/19) are nonfastidious Gram negative and Gram positive aerobic bacteria and H. influenzae.

The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

The provided document is a 510(k) clearance letter from the FDA for the Etest® for Trimethoprim/Sulphamethoxazole. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) summary.

Therefore, I cannot provide the requested information. The letter primarily focuses on the regulatory clearance and does not delve into the specifics of the underlying validation studies.

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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 µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This Etest 510(k) application is for MIC determination of Trimethoprim/sulphamethoxazole in the range of 0.002 - 32 µg/ml with Gram negative and Gram positive aerobic bacteria.

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The provided document is a 510(k) clearance letter from the FDA for the Etest® Trimethoprim/sulphamethoxazole, a device used for determining antimicrobial susceptibility. This type of document declares substantial equivalence and does not contain the acceptance criteria or a detailed study description as requested. It refers to a 510(k) submission, which would contain that information, but the submission itself is not provided here.

Therefore, I cannot provide the requested information based on the given text.

To be able to answer your questions, I would need a document that describes the actual performance study details, including:

• The study design (e.g., how the test set was created, ground truth establishment methods).
• The statistical analysis performed to evaluate the device's performance against predefined acceptance criteria.
• The specific acceptance criteria used.

Ask a specific question about this device