# K181412: Vitek MS

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 21, 2018 after 205 days
- Product code: QBN (Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates)
- Device class: 2
- Regulation: 21 CFR 866.3378
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170081 (2018). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170081: MALDI Biotyper CA System, Bruker Daltonik GmbH (2018) Summary page 17.

## Most influential descendants
- K212461: Vitek MS Prime (2022), 0 descendants of its own
- K193138: Colibri System (2021), 0 descendants of its own

## Indications for use
VITEK® MS is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections.

Source page: https://510kreport.com/device/K181412
Methodology: https://510kreport.com/methodology