Cleared Traditional

K142677 - MALDI Biotyper CA System (FDA 510(k) Clearance)

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

K142677 · Bruker Daltonics, Inc. · Microbiology device
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Mar 2015
Decision
189d
Days
Class 2
Risk

K142677 is an FDA 510(k) clearance for the MALDI Biotyper CA System. Classified as System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (product code PEX), Class II - Special Controls.

Submitted by Bruker Daltonics, Inc. (Billerica, US). The FDA issued a Cleared decision on March 27, 2015 after a review of 189 days - an extended review cycle.

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 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 Bruker Daltonics, Inc. devices

Submission Details

510(k) Number K142677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2014
Decision Date March 27, 2015
Days to Decision 189 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 102d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.