Amibacin Elution Disk for Autobac

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Amikacin Elution Disk for Autobac

Generic Name

DISCS, ELUTION

PMA Number

N50485 ↗

FDA Product Code

LTX

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

APPR Approved

PMA Supplement

S014

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See all devices from Organon Teknika Corp. →

• What is the Amikacin Elution Disc for Autobac used for in a clinical setting?

  The Amikacin Elution Disc for Autobac is designed specifically for antimicrobial susceptibility testing in microbiology laboratories. It delivers amikacin, an antibiotic, to determine how sensitive bacteria are to this medication by measuring diffusion through agar media in automated systems like the Autobac analyzer. This helps guide treatment decisions by identifying which bacteria are likely to respond to amikacin therapy.

• Is the Amikacin Elution Disc for Autobac single-use or reusable, and how should it be handled?

  The Amikacin Elution Disc for Autobac is a single-use device, meaning each disc is intended for one test only. It is supplied sterile, so no additional sterilization is required before use. After opening, it should be handled according to standard microbiology laboratory procedures, ensuring it is used immediately in the Autobac system to maintain sterility and accuracy of results.

• What automated system is this disc compatible with, and does it require any special preparation?

  This disc is designed exclusively for use in the Autobac automated microbiology analyzer system. No special preparation beyond standard laboratory procedures is required—it is sterile upon packaging and ready for immediate use in the system without further sterilization or handling steps.

• How was this device authorized for use in the United States?

  The Amikacin Elution Disc for Autobac received authorization through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number N50485. This route is typically used for devices that pose higher risks or require substantial clinical data to ensure safety and effectiveness, confirming its regulatory compliance for antimicrobial susceptibility testing.