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# Mass Spectrometer for Microorganism Detection into Class 2
- URL: https://www.fdaweb.com/mass-spectrometer-for-microorganism-detection-into-class-2/
- Published: 2017-10-24T12:00:00.000Z
- Updated: 2026-09-14T22:57:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139947

*Federal Register* notice: FDA has classified the mass spectrometer system for clinical use in identifying microorganisms into Class II (special controls). The action was taken in response to a 1/2013 *de novo* request from bioMérieux for its Vitek MS as a qualitative *in vitro* diagnostic device intended for identification of microorganisms cultured from human specimens. The device comprises an ionization source, a mass analyzer, and a spectral database. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-24/pdf/2017-23022.pdf?ref=fdaweb.com).