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# Class 2 for Non-microbial Analyte Detectors for Sepsis
- URL: https://www.fdaweb.com/class-2-for-non-microbial-analyte-detectors-for-sepsis/
- Published: 2017-10-24T12:00:00.000Z
- Updated: 2026-09-14T22:57:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139949

*Federal Register* notice: FDA has classified as Class 2 devices that detect and measure non-microbial analytes in human clinical specimens to aid in assessing patients with suspected sepsis. The action was taken in response to a 3/2015 Thermo Fisher Scientific *de novo* classification request for the BRAHMS PCT sensitive Kryptor device. The agency has identified it as an *in vitro* device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-24/pdf/2017-22994.pdf?ref=fdaweb.com).