Cleared Traditional

K212461 - VITEK MS PRIME (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212461 · bioMerieux, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
221d
Days
Class 2
Risk

K212461 is an FDA 510(k) clearance for the VITEK MS PRIME. Classified as Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (product code QBN), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 15, 2022 after a review of 221 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3378 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number K212461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 102d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.