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K Number
K983027
Device Name
TRIMETHOPRIM/SULPHAMETHOXAZOLE
Manufacturer
AB BIODISK
Date Cleared
1998-10-02

(32 days)

Product Code
JWY
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

§ 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).