Pixcell Medical Technologies, Ltd.

Pixcell Medical Technologies, Ltd. specializes in two primary types of in vitro diagnostic (IVD) devices: capillary blood collection tubes with K2EDTA anticoagulant and hematological cell analyzers. The blood collection tubes are designed for drawing small blood samples, while the analyzers, such as the HemoScreen and HemoScreen Hematology Analyzer, process these samples to assess blood parameters like cell counts and morphology. These devices are developed for point-of-care or laboratory use to support clinical diagnostics.

Pixcell Medical Technologies, Ltd. is based in the United States, which means its devices are subject to FDA regulatory oversight. The company’s products fall under the FDA’s jurisdiction, requiring authorization through pathways like the 510(k) premarket notification process. This pathway is used for devices deemed substantially equivalent to legally marketed predicates, ensuring compliance with US regulatory standards for safety and performance.

Pixcell Medical Technologies’ devices are listed in the FDA’s Unique Device Identifier (UDI) database, which provides a standardized identification system for medical devices to improve tracking and transparency. Additionally, their devices are authorized through the FDA’s 510(k) pathway, meaning they are included in the FDA’s premarket notification registry (510(k)). These listings help ensure traceability and compliance with US regulatory requirements.

Pixcell Medical Technologies’ devices are classified as Class II under the FDA’s regulatory framework. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness. The 510(k) pathway is commonly used for Class II devices to demonstrate that they are substantially equivalent to existing authorized devices, ensuring they meet regulatory standards before entering the market.