ETEST for Aztreonam

510(k) Number

K962794 ↗

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 for Aztreonam used for in a clinical setting?

  The ETEST for Aztreonam is a manual antimicrobial susceptibility test system used to determine the minimum inhibitory concentration (MIC) of aztreonam against bacterial isolates. This helps guide antimicrobial therapy decisions by providing quantitative susceptibility data in microbiology laboratories, ensuring clinicians can select the most effective antibiotic treatment.

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

  The ETEST for Aztreonam comes as ready-to-use test strips, designed for single-use in microbiology laboratories. No additional sterilization is required, and it aligns with standard laboratory practices for antimicrobial susceptibility testing. Each strip is meant for one-time use to ensure accurate and reliable results.

• Is the ETEST for Aztreonam reusable, and what storage guidelines apply?

  No, the ETEST for Aztreonam is explicitly designed for single-use only. Storage and handling follow standard antimicrobial susceptibility testing protocols, which typically involve maintaining the strips in a clean, dry environment away from direct light and extreme temperatures until use.

• What regulatory pathway was followed for the FDA clearance of this device?

  The ETEST for Aztreonam received FDA clearance through a traditional 510(k) process, classified as a Class II medical device under product code JWY. The submission was reviewed by the Microbiology (MI) Advisory Committee, and the device was determined to be substantially equivalent to a predicate device, ensuring compliance with special controls for antimicrobial susceptibility testing systems.