Amikacin

• • Ongoing Z-0817-2023 FDA Class II ·initiated 9 Nov 2022

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed

510(k) Number

K970210 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ab Biodisk →

• What is the Amikacin Manual Antimicrobial Susceptibility Test System used for?

  This test system is designed to evaluate the in vitro susceptibility of bacterial isolates to amikacin, helping microbiologists determine whether pathogens are resistant or susceptible to the antibiotic. By providing clear results, it supports informed decisions for targeted antimicrobial therapy, ensuring appropriate treatment selection in clinical settings.

• How is the Amikacin test kit supplied and intended for use?

  The kit is supplied as a manual test kit for laboratory use only. It requires preparation and interpretation by trained personnel following standardized microbiology protocols. Each test is intended for single-use, and the kit is not sterile, as it is engineered for controlled laboratory environments where sterility is not a primary concern.

• Is the Amikacin test kit sterile, and what are its storage requirements?

  The kit is not sterile, as it is designed for use in microbiology laboratories where standard aseptic techniques are already in place. Storage and handling should follow general microbiological laboratory practices to maintain test integrity and prevent contamination. Always refer to the manufacturer’s instructions for specific storage conditions.

• What regulatory clearance does the Amikacin test kit hold, and what class is it?

  The Amikacin Manual Antimicrobial Susceptibility Test System holds FDA 510(k) clearance under the reference number K970210. It is classified as a Class II medical device, indicating it poses minimal potential risk and is subject to special controls to ensure safety and effectiveness.

• Can this test kit be reused, and what are its key specifications?

  The kit is explicitly designed for single-use per test, meaning each test requires a new kit. Key specifications include its classification as a manual antimicrobial susceptibility test system, adherence to standardized testing protocols, and its regulatory filing under product code JWY. The system is intended for in vitro use only and does not require sterility due to its controlled laboratory environment.