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Sensititre 18-24 HR Susceptibility Plates

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111615

by Trek Diagnostic Systems

Identifiers

510(k) Number
K111615 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 HR Susceptibility Plates are an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative isolates comprising of Enterobacteriaceae, Pseudomonas aeruginosa, and other non-Enterobacteriaceae, as well as gram-negative and gram-positive organisms. The system utilizes an AutoReader to perform susceptibility testing.

The device is supplied as plates for use in clinical microbiology laboratories. It received FDA 510(k) clearance under K111615 and is classified as a Class II device under regulation number 866.1640 with product code JWY. The device is intended for in vitro diagnostic use and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.

Frequently asked questions

What is the Sensititre 18-24 HR Susceptibility Plate used for?

The Sensititre 18-24 HR Susceptibility Plate is used for in vitro diagnostic susceptibility testing of non-fastidious Gram-negative isolates such as Enterobacteriaceae and Pseudomonas aeruginosa, as well as other Gram-negative and Gram-positive organisms in clinical microbiology laboratories.

How is the Sensititre 18-24 HR Susceptibility Plate supplied and used?

The device is supplied as plates designed for use with an AutoReader system to perform automated susceptibility testing in clinical microbiology laboratories.

Is the Sensititre 18-24 HR Susceptibility Plate sterile or single-use?

The provided data does not describe the Sensititre 18-24 HR Susceptibility Plate as sterile, single-use, reusable, or MRI-safe; therefore, no claims about sterility or reusability can be made based on the available information.

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: K073424 - Sensititre 18-24 Hour Susceptibility Plates, Sensititre 18-24 Hour Susceptibility Plates, SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES by TREK DIAGNOSTIC ..., Sensititre 18-24 Hours Susceptibility Plates

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trek Diagnostic Systems

Sources (1)

  • FDA 510(k) K111615 24 fields · synced Sep 27, 2026