ETEST Ciprofloxacin

• • Terminated Z-1524-2017 FDA Class II ·initiated 15 Dec 2016

  Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

510(k) Number

K981138 ↗

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 Ciprofloxacin used for in a clinical setting?

  The ETEST Ciprofloxacin is a manual antimicrobial susceptibility test system that determines how sensitive bacterial isolates are to the antibiotic ciprofloxacin. By measuring the minimum inhibitory concentration (MIC) through gradient diffusion, it helps clinicians select the most effective antibiotic therapy for treating infections caused by these bacteria.

• Is the ETEST Ciprofloxacin single-use or reusable?

  The ETEST Ciprofloxacin is designed as a sterile, single-use device. Each strip is individually packaged and intended for one-time use in controlled clinical laboratory settings, ensuring accuracy and preventing cross-contamination.

• How should the ETEST Ciprofloxacin strips be stored?

  The strips should be stored following standard aseptic practices for microbiological reagents. Since they are sterile and single-use, they must be kept in a clean, dry environment to maintain their integrity until use, avoiding exposure to moisture or contamination.

• What regulatory pathway was followed for FDA clearance of the ETEST Ciprofloxacin?

  The ETEST Ciprofloxacin received FDA clearance through a traditional 510(k) review process (K981138) under product code JWY, classified as a Class II device under special controls for manual antimicrobial susceptibility test systems. The decision was made by the Microbiology (MI) Advisory Committee in 1998.

• Do the ETEST Ciprofloxacin strips require any special preparation before use?

  No additional preparation beyond standard microbiological techniques is required. The strips are pre-packaged and ready for use, adhering to the gradient diffusion method without needing further handling or activation before application in testing.