OpGen, Inc. Submits Updated 510(k) Summary to FDA For Acuitas AMR Gene Panel for Isolates
June 07, 2021 at 07:30 am EDT
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OpGen, Inc. announced that it has submitted an updated 510(k) summary document to the U.S. FDA for its Acuitas AMR Gene Panel for Isolates. This document incorporates all of the FDA’s requested updates to various key documents such as the Package Insert, Electronic User Guide, and Operator Manual. Consistent with the FDA’s previously communicated timeline, the FDA provided substantive feedback on all of these key documents by the end of May 2021. The FDA previously informed OpGen that it intends to complete its review by the end of August 2021, but that it cannot commit to a timeline and that such timeline can be affected by various factors, including the FDA’s other workload and public health priorities.
OpGen, Inc. (OpGen) is a precision medicine company that uses molecular diagnostics and informatics to combat infectious diseases. The Company, through its subsidiaries, is focused on developing and commercializing molecular microbiology solutions helping to guide clinicians with actionable information infections caused by multidrug-resistant microorganisms (MDROs). The Companyâs product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, next-generation sequencing (NGS) technology and AI-powered bioinformatics solutions for AMR surveillance, outbreak analysis, and antibiotic response prediction including ARESiss, ARESid, ARESasp, and AREScloud, as well as the Curetis CE- in vitro diagnostics (IVD)-marked polymerase chain reaction (PCR)-based severe acute respiratory syndrome (SARS)-CoV-2 test kit. The Companyâs subsidiaries include Curetis GmbH and Ares Genetics GmbH.
OPGEN, INC. 
