Etest for Gemifloxacin

510(k) Number

K042390 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ab Biodisk →

• What is the primary purpose of the Etest for Gemifloxacin in a clinical setting?

  The Etest for Gemifloxacin is used to determine how susceptible bacteria are to the antibiotic gemifloxacin. It employs a gradient strip method to measure the minimum inhibitory concentration (MIC) of the drug, helping laboratories assess bacterial resistance patterns precisely. This aids clinicians in tailoring antibiotic treatment based on real-time susceptibility data.

• How is the Etest for Gemifloxacin supplied, and is it reusable?

  The Etest for Gemifloxacin is supplied as a sterile, single-use test strip containing a gradient of gemifloxacin concentrations (ranging from 0.002 to 32 µg/mL). Because it is designed for one-time use, reuse is not recommended or intended, ensuring accuracy and sterility for each test.

• What concentration range does the test strip cover, and how does this help in testing?

  The test strip covers a gradient of gemifloxacin concentrations from 0.002 µg/mL to 32 µg/mL. This broad range allows for precise measurement of the MIC, enabling laboratories to determine whether bacteria are susceptible, intermediate, or resistant to the antibiotic, which is critical for guiding effective treatment decisions.

• Where should the Etest for Gemifloxacin be stored, and are there any special handling requirements?

  Since the Etest is a sterile, single-use device, it should be stored in a clean, dry environment protected from extreme temperatures and moisture. The manufacturer’s instructions (not provided here) should be followed for optimal shelf life and to maintain the integrity of the gradient strip until use. Avoid exposure to direct sunlight or contamination.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

  The Etest for Gemifloxacin received FDA 510(k) clearance under a substantial equivalence determination (K042390) through the traditional review pathway, classified as a Class II medical device. This classification reflects its role as a manual antimicrobial susceptibility test system, which carries moderate risk and requires regulatory oversight to ensure safety and effectiveness in clinical microbiology.