Sensititre 18-24 Hour Susceptibility Plates with Trovafloxacin

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K983301 ↗

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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• Sensititre 19 - 24 Hour Susceptibility Plates with Levofloxacin

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• Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin

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See all devices from Accumed Intl., Inc. →

• What is the primary purpose of the Sensititre 18–24 Hour Susceptibility Plates With Trovafloxacin in a clinical setting?

  These plates are designed for in vitro antimicrobial susceptibility testing to determine how bacteria respond to trovafloxacin. By measuring the minimum inhibitory concentration (MIC) of the antibiotic, laboratories can assess whether bacterial strains are susceptible or resistant, helping guide appropriate treatment decisions for infections caused by gram-negative and gram-positive organisms.

• Are these plates sterile, and how should they be handled to maintain integrity?

  The Sensititre 18–24 Hour Susceptibility Plates With Trovafloxacin are non-sterile consumables intended for single-use only. Since they are not sterile, they should be handled in a clean environment to avoid contamination. Follow standard microbiological practices, such as using aseptic techniques when preparing bacterial inocula, to ensure accurate and reliable test results.

• How long does it typically take to perform a susceptibility test using these plates, and what organisms can they evaluate?

  The plates are designed for 18–24 hour incubation periods, allowing quantitative MIC testing for both gram-negative and gram-positive bacteria. This timeframe aligns with standard antimicrobial susceptibility testing protocols to determine bacterial response to trovafloxacin within the specified dilution range of 0.002–4 µg/mL.

• What regulatory pathway was followed for FDA clearance of these susceptibility plates?

  The Sensititre plates received FDA 510(k) clearance (K983301) under the Traditional Review pathway, classified as a Class II device (product code JWY) in the *Manual Antimicrobial Susceptibility Test Systems* category. The submission was reviewed by the Microbiology (MI) Advisory Committee and determined to be *Substantially Equivalent* to a predicate device, ensuring compliance with FDA regulations for antimicrobial testing systems.