Not Cleared Direct

MALDI Biotyper CA System (DEN170081) - FDA 510(k) Clearance

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

DEN170081 · Bruker Daltonik GmbH · Microbiology device
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Apr 2018
Decision
203d
Days
Class 2
Risk

DEN170081 is an FDA 510(k) submission (not cleared) for the MALDI Biotyper CA System. Classified as Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (product code QBN), Class II - Special Controls.

Submitted by Bruker Daltonik GmbH (Bremen, DE). The FDA issued a Not Cleared (DENG) decision on April 20, 2018 after a review of 203 days.

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 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.

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Submission Details

510(k) Number DEN170081 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2017
Decision Date April 20, 2018
Days to Decision 203 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 102d · This submission: 203d
Pathway characteristics

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.