ESCREEN, INC.

ESCREEN, INC. specialises in in-vitro diagnostic (IVD) devices focused on detecting multiple drugs of abuse. Their portfolio includes rapid immunoassay kits, disposable collection cups (like eCUP™, mCup®, and xCup™), and handheld readers (e.g., eREADER™, xReader System) for point-of-care testing. They also produce photometric/spectroscopic immunoassay analysers designed for laboratory use, such as the eScreen eReader and eScreen eCup, which provide immediate results in clinical or non-clinical settings.

ESCREEN, INC. is based in the United States, where their devices are subject to FDA oversight. The company’s products fall under FDA-regulated classifications, including Class I and Class II devices. Some of their devices are authorised through the 510(k) pathway, while others are listed under the Unique Device Identifier (UDI) system, ensuring compliance with U.S. diagnostic performance and safety standards.

ESCREEN, INC.’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) pathway for certain products and the Unique Device Identifier (UDI) system for others. These registries ensure transparency and compliance with U.S. regulatory requirements for in-vitro diagnostics, including drug-of-abuse testing devices.

The FDA classifies ESCREEN, INC.’s devices into two main categories: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory scrutiny, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the level of regulatory oversight needed to mitigate risks.

ESCREEN, INC.’s devices are designed for flexibility and convenience, combining disposable collection cups (like eCUP™ or mCup®) with handheld readers (e.g., eREADER™) for rapid, point-of-care testing. Their photometric/spectroscopic analysers cater to laboratory settings, offering precise results for clinical use. The company’s portfolio spans both rapid immunoassay kits for immediate results and more advanced analysers, ensuring broad applicability in diverse testing environments.