Critical Care Diagnostics, Inc. (Dba Critical Diag

Critical Care Diagnostics, Inc. specializes in diagnostic tests. Specifically, they produce the PRESAGE ST2 assay, a blood test designed to measure ST2 levels. Elevated ST2 is linked to cardiovascular risk and can help monitor heart failure progression, making this device relevant for cardiology and critical care settings.

Critical Care Diagnostics, Inc. is headquartered in the United States. Since the company operates within the US market, its devices—such as the PRESAGE ST2 assay—are subject to FDA regulations. The US FDA classifies this assay as a Class II device, indicating moderate risk and requiring compliance with specific controls, including the 510(k) pathway for market authorization.

The PRESAGE ST2 assay from Critical Care Diagnostics, Inc. is listed under the FDA’s 510(k) pathway, meaning it has undergone premarket notification review to demonstrate substantial equivalence to a legally marketed predicate device. This classification ensures the device meets US regulatory requirements for commercial distribution.

The PRESAGE ST2 assay is classified as a Class II device in the US. This classification is determined by the FDA based on the device’s intended use and potential risk. Class II devices require special controls beyond general controls (like good manufacturing practices) to ensure safety and effectiveness. For diagnostic tests like this, it ensures rigorous validation of accuracy, reliability, and clinical performance before market authorization.