Cleared Traditional

VITEK MS PRIME

K212461 · bioMerieux, Inc. · Microbiology
Mar 2022
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K212461 is an FDA 510(k) clearance for the VITEK MS PRIME, 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 March 15, 2022, 221 days after receiving the submission on August 6, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3378.

Submission Details

510(k) Number K212461 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2021
Decision Date March 15, 2022
Days to Decision 221 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.