> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bruker Daltonik Gains Marketing OK for C. auris Detection
- URL: https://www.fdaweb.com/bruker-daltonik-gains-marketing-ok-for-c-auris-detection/
- Published: 2018-04-20T12:00:00.000Z
- Updated: 2026-09-15T00:00:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141270

FDA has allowed the *de novo* marketing for Bruker Daltonik’s Bruker Maldi Biotyper CA system for identifying *C. auris.* [FDA says](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605336.htm?ref=fdaweb.com) this is the first test to identify the emerging pathogen, which can cause serious infections in hospitalized patients. The expanded detection for the test system adds the its already-cleared uses for identifying 333 species or species groups, covering 424 clinically relevant bacteria and yeast species.

The device uses a technology known as matrix-assisted laser desorption/ionization mass spectrometry in combination with a reference organism database. “Microorganisms cultured from patient samples are ionized by the laser to produce an organism spectrum, which is matched to the reference organism database for proper identification,” the agency says.

FDA’s marketing decision was based on an evaluation of data showing that the “system can reliably identify *C. auris* 100% of the time,” according to the agency. “Risks associated with use of the system may include no identification or misidentification of a microorganism.”