Federal Register #2026-12900

FDA Classifies Preeclampsia Prognostic and SARS-CoV-2 Serology Tests as Class II Medical Devices

This FDA final order announces the regulatory classification of two in vitro diagnostic medical devices: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - OEMs and Vendors: - BRAHMS GmbH (manufacturer of the BRAHMS sFlt1/PlGF KRYPTOR Test System) - Ortho-Clinical Diagnostics, Inc. (manufacturer of VITROS Immunodiagnostic Products) - Products/Devices Classified: - Prognostic test for development or progression of preeclampsia - BRAHMS sFlt1/PlGF KRYPTOR Test System (in vitro diagnostic device for risk assessment, not diagnosis) - SARS-CoV-2 serology tests - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator - Notable Requirements: - Both device types are classified as Class II medical devices, subject to special controls for safety and effectiveness - Special controls include design verification/validation, labeling, and practitioner training - The classification is regulatory, not a procurement solicitation; no purchase quantities or part numbers for procurement are specified

Description

The Food and Drug Administration (FDA) is classifying the prognostic test for development or progression of preeclampsia into class II (special controls). This in vitro diagnostic device is intended to measure one or more analytes obtained from human samples and is indicated as an aid in the risk assessment for the development or progression of preeclampsia, but not for diagnosis. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The order is effective June 26, 2026, with the classification applicable since May 18, 2023.

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