Etest Package Insert

Full name

(Modified) Etest Package Insert

510(k) Number

K964236 ↗

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 primary purpose of the Etest Package Insert in a clinical setting?

  The Etest Package Insert is designed to determine the minimum inhibitory concentrations (MICs) of antimicrobial agents against bacterial isolates. This helps microbiologists analyze bacterial resistance patterns, enabling clinicians to select the most effective antibiotic therapy for patients.

• Is the Etest Package Insert intended for single-use or repeated use in a lab?

  The Etest Package Insert is explicitly supplied as a single-use package, meaning each strip or strip set is meant for one-time use in antimicrobial susceptibility testing. This ensures accuracy and reliability, as reuse could compromise sterility and test integrity.

• What storage conditions are critical for maintaining the device’s performance?

  While the exact storage conditions are detailed in the accompanying package insert, sterility is emphasized as essential for accurate results. Proper storage—likely including protection from moisture, extreme temperatures, and contamination—must be followed to preserve the device’s integrity and functionality.

• How is this device regulated by the FDA, and what does that mean for buyers?

  The Etest Package Insert is cleared through the FDA’s 510(k) process (K964236) under the classification of Class II medical devices (regulation number 866.1640). This means it has undergone review by the Microbiology (MI) Advisory Committee to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for antimicrobial susceptibility testing.

• What types of bacterial isolates can the Etest Package Insert be used to test?

  The device is intended for determining MICs of antimicrobial agents *against bacterial isolates*, though the specific bacterial species or strains tested are not detailed in the provided data. It is used in clinical microbiology laboratories to guide antibiotic therapy based on resistance patterns, so compatibility depends on the lab’s standard practices and the device’s broader antimicrobial spectrum.