Cleared Traditional

MBT Sepsityper (K193419) - FDA 510(k) Clearance

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

K193419 · Bruker Daltonik GmbH · Microbiology device
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Dec 2020
Decision
384d
Days
Class 2
Risk

K193419 is an FDA 510(k) clearance for the MBT Sepsityper. Classified as Mass Spectrometry, Microorganism Identification, Blood Culture (product code QNJ), Class II - Special Controls.

Submitted by Bruker Daltonik GmbH (Bremen, DE). The FDA issued a Cleared decision on December 27, 2020 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K193419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2019
Decision Date December 27, 2020
Days to Decision 384 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 102d · This submission: 384d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNJ Mass Spectrometry, Microorganism Identification, Blood Culture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3378
Definition Blood Culture Processing Device That Includes Associated Reagents That Are Intended To Concentrate And Purify Microbial Cells From Blood Culture Samples Identified As Positive By A Continuous Monitoring Blood Culture System With Organisms Subsequently Identified By Spectrometry.
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.