Cleared Traditional

K130831 - MALDI BIOTYPER CA (MBT-CA) SYSTEM

K130831 is an FDA 510(k) clearance for MALDI BIOTYPER CA (MBT-CA) SYSTEM, manufactured by Bruker Daltonics, Inc.. The device is a Class 2 Microbiology device with product code PEX cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K130831 · Bruker Daltonics, Inc. · Microbiology device
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Nov 2013
Decision
240d
Days
Class 2
Risk

K130831 is an FDA 510(k) clearance for the MALDI BIOTYPER CA (MBT-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. (Beverly, US). The FDA issued a Cleared decision on November 21, 2013 after a review of 240 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

FDA 510(k) Submission Details - K130831

510(k) Number K130831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2013
Decision Date November 21, 2013
Days to Decision 240 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
138d slower than avg
Panel avg: 102d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEX Device Classification - Class 2, Special Controls

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.