Etest Grepafloxacin

510(k) Number

K980773 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• System U3 for Tetracycline

  Class II

  FDA 510(k) K983571 Active Cleared 30 Dec 1998

• ETEST Trovafloxacin

  Class II

  FDA 510(k) K980603 Active Cleared 13 May 1998

• Etest Esbl CT/Ctl Strip; Etest Esbl Tz/Tzl Strip

  Class II

  FDA 510(k) K001547 Active Cleared 7 Aug 2000

• Etest Vancomycin Open recall

  Class II

  FDA 510(k) K980348 Active Cleared 29 May 1998

• Etest Submission for Cefotetan

  Class II

  FDA 510(k) K961517 Active Cleared 5 Jul 1996

• Trimethoprim/Sulphamethoxazole

  Class II

  FDA 510(k) K983027 Active Cleared 2 Oct 1998

See all devices from Ab Biodisk →

• What is the ETEST Grepafloxacin used for?

  The ETEST Grepafloxacin is a manual antimicrobial susceptibility test system designed to determine the minimum inhibitory concentration (MIC) of grepafloxacin against bacterial isolates. By measuring bacterial resistance or susceptibility through gradient diffusion strips, it helps microbiology labs assess how effectively grepafloxacin can inhibit bacterial growth, guiding appropriate antibiotic treatment decisions.

• How is the ETEST Grepafloxacin supplied and intended for use?

  The ETEST Grepafloxacin is supplied as a single-use test system, meaning each strip is intended for one test only. It is specifically designed for use in microbiology laboratories to perform antimicrobial susceptibility testing. The non-sterile nature of the strips requires adherence to standard microbiological practices during handling to ensure accurate and reliable results.

• Is the ETEST Grepafloxacin sterile, and how should it be stored?

  The ETEST Grepafloxacin strips are non-sterile, so they must be handled in accordance with standard microbiological practices to prevent contamination. Proper storage is critical to maintaining the integrity and accuracy of the test results. Store the strips in a cool, dry place, away from direct sunlight and extreme temperatures, following the manufacturer’s guidelines to preserve their effectiveness until use.

• What regulatory clearance does the ETEST Grepafloxacin hold?

  The ETEST Grepafloxacin holds FDA 510(k) clearance under the reference number K980773. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under regulation 866.1640. This classification reflects its role in antimicrobial susceptibility testing within microbiology.

• Can the ETEST Grepafloxacin strips be reused?

  No, the ETEST Grepafloxacin strips are designed for single-use only. Reusing them could compromise the accuracy of the MIC results due to potential contamination or degradation of the gradient diffusion strip. Always use a fresh strip for each test to ensure reliable and reproducible outcomes in determining bacterial susceptibility to grepafloxacin.