Not Cleared Direct

VITEK MS (DEN130013) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN130013 · bioMerieux, Inc. · Microbiology device
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Aug 2013
Decision
231d
Days
Class 2
Risk

DEN130013 is an FDA 510(k) submission (not cleared) for the VITEK MS. Classified as System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (product code PEX), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Not Cleared (DENG) decision on August 21, 2013 after a review of 231 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3361 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number DEN130013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 02, 2013
Decision Date August 21, 2013
Days to Decision 231 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 102d · This submission: 231d
Pathway characteristics

Device Classification

Product Code PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3361
Definition A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ Ionization - Time Of Flight (maldi-tof) For The Identification Of Microorganisms Cultured From Human Specimens.
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.

Regulatory Peers - PEX System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Devices cleared under the same product code (PEX) and FDA review panel - the closest regulatory comparables to DEN130013.
VITEK MS
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