The U.S. FDA said some tests for sepsis using non-microbial analytes will henceforth be deemed class II devices thanks to a de novo application by a subsidiary of Thermofisher Scientific. Brahms GMBH of Hennigsdorf, Germany, won a class II designation for its Kryptor test in February 2016, the agency said. The generic device type is described in §866.3215 in Title 21 of the Code of Federal Regulations. The FDA also reported that mass spectrometry systems for use in diagnosing sepsis would likewise be deemed class II devices after a de novo application by Biomérieux Inc. of Marcy-l'Étoile, France. The agency noted that it had granted the de novo in 2013, which will appear in Title 21 of the Code of Federal Regulations at §866.3361.

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