Cleared Traditional

K142677 - MALDI Biotyper CA System

K142677 is an FDA 510(k) clearance for MALDI Biotyper 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 189-day FDA review.

K142677 · Bruker Daltonics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K142677

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 102d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02098226 Unknown Observational Industry-sponsored

Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts

Method Comparison Protocol: MALDI Biotyper-Clinical Applications (MBT-CA) Phase 2

3000
Patients (est.)
1
Site
Condition studied Infection
Eligibility All sexes
Sponsor Bruker Daltonics (industry)
Started 2013-09-01 → Primary completion 2014-09-01 → Completed 2015-03-01
Primary outcome
Substantial equivalence of MBT-CA with sequencing concerning determination of the respective bacteria and yeasts
View full study on ClinicalTrials.gov

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 K142677.
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
K163536 · Bruker Daltonik GmbH · Jul 2017
VITEK MS
K162950 · bioMerieux, Inc. · Jul 2017
MALDI BIOTYPER CA (MBT-CA) SYSTEM
K130831 · Bruker Daltonics, Inc. · Nov 2013
VITEK MS
DEN130013 · bioMerieux, Inc. · Aug 2013