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Sensititre AIM

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K110331

by Trek Diagnostic Systems Ltd

Identifiers

510(k) Number
K110331 FDA 510(k)
FDA Product Code
LIE 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 AIM is a microprocessor-controlled automated inoculation delivery system classified as a Reagent/Device for Inoculum Calibration. It is designed to automate the precise delivery of 50 µL inoculum volumes to Sensititre 96-well microtitration plates, facilitating in vitro antimicrobial susceptibility testing and microbial identification.

This device is supplied with disposable dosing heads and operates in microbiology laboratories. It is intended for single-use applications, adhering to IVDR and FDA 510(k) clearance under the classification of Class II medical devices. Storage and handling follow standard microbiological protocols, with regulatory compliance ensured through submissions to the Microbiology (MI) Advisory Committee.

Frequently asked questions

What is the primary purpose of the Sensititre AIM in a microbiology lab?

The Sensititre AIM automates the precise delivery of 50 microliters of inoculum to Sensititre 96-well microtitration plates, streamlining in vitro antimicrobial susceptibility testing and microbial identification. This reduces manual error and improves consistency in lab workflows.

Is the Sensititre AIM designed for single-use or repeated use?

The Sensititre AIM is explicitly designed for single-use applications, including its disposable dosing heads. This design choice aligns with microbiological best practices to prevent cross-contamination and ensure sterility between tests.

How should the Sensititre AIM be stored and handled?

Storage and handling follow standard microbiological protocols, as the device is intended for use in microbiology laboratories. While specific storage conditions aren’t detailed, adherence to general lab hygiene and environmental controls (e.g., temperature, cleanliness) is implied to maintain performance and compliance.

What regulatory pathways does the Sensititre AIM follow, and how does that affect its use?

The Sensititre AIM is cleared under both the FDA’s 510(k) pathway (as a Class II device) and the EU’s In Vitro Diagnostic Regulation (IVDR). This means it meets U.S. and EU standards for antimicrobial susceptibility testing automation, ensuring its use is compliant with both regional regulatory requirements.

Does the Sensititre AIM require any special accessories, and if so, what are they?

The device is supplied with disposable dosing heads, which are essential for single-use inoculum delivery. These heads are part of the system’s design to ensure precision and sterility, and they must be replaced after each use to maintain accuracy and compliance with microbiological protocols.

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: Thermo Scientific Microbiology | Trek | Product Specifications, TREK DIAGNOSTIC SYSTEMS LIMITED V3020 Sensititre AIM™, Thermo Scientific™ Sensititre AIM™ Automated ... - Fisher Sci

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trek Diagnostic Systems Ltd
FDA Applicant
Trek Diagnostic Systems, Ltd.

Sources (2)

  • FDA 510(k) K110331 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026