# K212461: Vitek MS Prime

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Mar 15, 2022 after 221 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: 2 generations back to DEN170081 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181412: Vitek MS, bioMerieux, Inc. (2018) Summary page 9.

## Indications for use
VITEK© MS PRIME 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 PRIME 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 and fungal infections.

Source page: https://510kreport.com/device/K212461
Methodology: https://510kreport.com/methodology