ETEST Trovafloxacin

510(k) Number

K980603 ↗

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 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

• Etest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus Spp. and Anaerobic Bacteria

  Class II

  FDA 510(k) K052366 Active Cleared 13 Oct 2005

See all devices from Ab Biodisk →

• What is the ETEST Trovafloxacin used for?

  The ETEST Trovafloxacin is a manual antimicrobial susceptibility test system designed to determine the minimum inhibitory concentration (MIC) of trovafloxacin against bacterial isolates. This quantitative data helps clinicians select the most effective antibiotic therapy by assessing bacterial resistance levels, ensuring targeted and evidence-based treatment decisions in clinical microbiology settings.

• How is the ETEST Trovafloxacin supplied and prepared for use?

  The ETEST Trovafloxacin is supplied as a single-use test strip, requiring no additional sterilization beyond standard laboratory hygiene. Before use, bacterial colonies must be suspended to achieve a 0.5 McFarland turbidity standard, following standardized microbiological protocols to ensure accurate and reliable susceptibility testing results.

• Is the ETEST Trovafloxacin strip reusable or single-use?

  The ETEST Trovafloxacin strip is explicitly designed for single-use only. This ensures consistency, sterility, and reliability in antimicrobial susceptibility testing, as reuse could compromise accuracy and introduce contamination risks in clinical microbiology environments.

• What storage and handling guidelines apply to the ETEST Trovafloxacin?

  The ETEST Trovafloxacin must be stored and handled according to standard microbiological practices to maintain its integrity and performance. Proper storage conditions—typically at room temperature, protected from light and moisture—are critical to preserving the strip’s stability and ensuring accurate MIC readings when used as intended.

• What regulatory pathway does the ETEST Trovafloxacin follow?

  The ETEST Trovafloxacin is regulated under the FDA’s 510(k) clearance process (K980603) and classified as a Class II medical device under special controls for manual antimicrobial susceptibility test systems. This pathway ensures the device meets established safety and performance standards for use in clinical microbiology laboratories.