Cleared Traditional

VITEK MS

K181412 · bioMerieux, Inc. · Microbiology
Dec 2018
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K181412 is an FDA 510(k) clearance for the VITEK MS, a Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (Class II — Special Controls, product code QBN), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on December 21, 2018, 205 days after receiving the submission on May 30, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3378.

Submission Details

510(k) Number K181412 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2018
Decision Date December 21, 2018
Days to Decision 205 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QBN — Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3378
Definition The Maldi Biotyper Ca System Is A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ionization - Time Of Flight (maldi-tof) For The Identification And Differentiation Of Microorganisms Cultured From Human Specimens. The Maldi Biotyper Ca 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.