Miris AB

Miris AB specialises in in vitro diagnostics (IVD) devices, primarily single-use optical laboratory instrument calibrators and controls, such as the Miris Check™ and Miris Calibration Control Kit™. They also produce breast milk analysers like the Miris Human Milk Analyzer™, which assess nutritional content, and manual wash/cleaning solutions for IVD equipment disinfection, such as the Miris Cleaner™. These products are designed to standardise performance testing and ensure equipment reliability in laboratory settings.

Miris AB is based in the United States, which means its devices are regulated under the FDA’s pathways. Since the company’s products fall under in vitro diagnostics (IVD), they are subject to FDA requirements like 510(k) clearances for market authorisation and must comply with the Unique Device Identifier (UDI) system. The U.S. regulatory framework directly influences how these devices are classified, listed, and monitored in the FDA’s databases.

Miris AB’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) clearance process and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of authorised devices, allowing healthcare providers, regulators, and other stakeholders to verify compliance and device details. The inclusion in these systems reflects the company’s adherence to FDA requirements for IVD products.

Miris AB’s devices are classified as either Class I or Class II under FDA regulations. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety. For example, single-use calibrators and controls like the Miris Check™ may fall under Class I due to lower risk, while breast milk analysers like the Miris Human Milk Analyzer™ could be classified as Class II due to their role in diagnostic testing. This classification determines the regulatory pathway and oversight required for each device.

The FDA’s 510(k) clearance process applies to devices that are not exempt and are deemed substantially equivalent to a legally marketed predicate device. Since Miris AB’s products—such as breast milk analysers and certain calibrators—perform diagnostic functions or involve moderate risk (e.g., ensuring accurate test results), they require this pathway to demonstrate safety and effectiveness. The 510(k) submission provides evidence that the device meets FDA standards for its intended use, ensuring it complies with regulatory requirements before entering the market.