Lumos Diagnostics, Inc.

Lumos Diagnostics, Inc. specializes in in vitro diagnostic (IVD) devices, primarily rapid immunochromatographic test (ICT) kits and assays for clinical use. Their portfolio includes antigen tests for influenza A/B and SARS-CoV-2, as well as point-of-care assays that detect bacterial and non-bacterial infections by analyzing host immune response markers. They also produce control kits for clinical chemistry analyte profiles, enabling rapid, on-site diagnostic testing in clinical settings.

Lumos Diagnostics, Inc. is based in the United States, which means its devices are regulated under the FDA’s jurisdiction. Since the company’s products are in vitro diagnostics, they fall under FDA pathways like 510(k) clearances and de novo classifications, ensuring compliance with U.S. regulatory standards for diagnostic testing.

Lumos Diagnostics, Inc.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. These registries document the authorised status of their products, including rapid antigen tests and point-of-care assays, under FDA oversight. The inclusion in these databases reflects compliance with U.S. regulatory requirements for in vitro diagnostics.

Lumos Diagnostics, Inc.’s devices are classified under FDA categories including Class I, Class II, and Notified Body (N) designations. Class I devices generally pose minimal risk, while Class II devices require special controls to ensure safety and effectiveness. The N designation indicates certain assays follow alternative regulatory pathways, reflecting variations in risk and regulatory oversight for different diagnostic tests.

Lumos Diagnostics, Inc.’s rapid diagnostic tests are designed for point-of-care use, enabling quick, on-site detection of infections like influenza, SARS-CoV-2, and bacterial/non-bacterial markers through host immune responses. Their immunochromatographic test (ICT) kits and control systems are tailored for clinical settings, offering rapid results while adhering to FDA-authorised pathways like 510(k) clearances and de novo classifications, ensuring reliability and regulatory compliance.