# K162950: Vitek MS

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jul 22, 2017 after 271 days
- Product code: PEX (System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates)
- Device class: 2
- Regulation: 21 CFR 866.3361
- 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 DEN130013 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130013: Vitek MS, bioMerieux, Inc. (2013) Summary page 9.
- DEN130013: Vitek MS, bioMerieux, Inc. (2013). Our reading of the summary gave K124067, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130013, Vitek MS (bioMerieux, Inc.), granted Aug 21, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 9.

## 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 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/K162950
Methodology: https://510kreport.com/methodology