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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezoli…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242653

by Thermo Fisher Scientific

Identifiers

510(k) Number
K242653 FDA 510(k)
FDA Product Code
JWY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1640 FDA 510(k)
Regulation Number
866.1640 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sensititre 18–24 Hour MIC/Breakpoint Susceptibility System with Linezolid is a manual antimicrobial susceptibility test system designed to determine the minimum inhibitory concentration (MIC) and breakpoint susceptibility of non-fastidious gram-positive isolates. It evaluates bacterial resistance to linezolid within a dilution range of 0.25–32 µg/mL, supporting clinical microbiology laboratories in adhering to standardized antimicrobial testing protocols. The system aids in guiding targeted antibiotic therapy by providing quantitative susceptibility data for pathogens such as Staphylococcus and Enterococcus species.

This system is supplied as a disposable, ready-to-use panel for in vitro diagnostic use, requiring no additional preparation beyond microbial inoculation. It is classified under FDA regulation 866.1640 as a Class II device and has received FDA 510(k) clearance (K242653) under the Traditional pathway, with a decision of Substantially Equivalent (SESE). The product code JWY identifies it within the OpenFDA database, and its use is restricted to microbiology settings. Sterility and single-use compliance are implied by its design as a consumable test panel, though explicit sterility claims are not stated in the regulatory data.

Frequently asked questions

What is the Sensititre 18-24 hour MIC system with Linezolid used for?

This system determines the minimum inhibitory concentration (MIC) and breakpoint susceptibility of non-fastidious gram-positive bacteria, such as *Staphylococcus* and *Enterococcus* species, to linezolid within the 0.25–32 µg/mL dilution range. It helps clinical microbiology labs provide quantitative data to guide precise antibiotic therapy decisions, ensuring adherence to standardized antimicrobial testing protocols.

How is the Sensititre Linezolid MIC system supplied and prepared for use?

The system is supplied as a disposable, ready-to-use panel designed for in vitro diagnostic use. No additional preparation is required beyond inoculating the panel with the microbial sample. This eliminates the need for manual dilution or setup, streamlining workflow in microbiology labs.

Is the Sensititre Linezolid MIC system sterile and single-use?

The system is designed as a consumable test panel, implying sterility and single-use compliance. While explicit sterility claims are not stated in regulatory data, its disposable nature ensures each panel is intended for one-time use to prevent cross-contamination and maintain accuracy.

What regulatory pathway and classification apply to this device?

The Sensititre Linezolid MIC system is classified as a Class II medical device under FDA regulation 866.1640 and has received FDA 510(k) clearance (K242653) through the Traditional pathway, determined to be Substantially Equivalent (SESE). It is restricted for use in microbiology settings and is listed in the OpenFDA database under product code JWY.

What types of bacteria does this system evaluate for linezolid resistance?

The system evaluates non-fastidious gram-positive isolates, specifically targeting pathogens like *Staphylococcus* and *Enterococcus* species. It provides susceptibility data for linezolid within the specified dilution range, helping clinicians identify bacterial resistance patterns to optimize treatment strategies.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF K242653 - accessdata.fda.gov, The Sensititre 18-24 hour MIC or Breakpoint… - FDA.report, The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with ..., PDF Thermo Scientific Sensititre Plate Guide

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thermo Fisher Scientific

Sources (1)

  • FDA 510(k) K242653 24 fields · synced Oct 6, 2026