Cleared Traditional

K172708 - T2Bacteria Panel (FDA 510(k) Clearance)

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

K172708 · T2biosystems, Inc. · Microbiology device
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May 2018
Decision
258d
Days
Class 2
Risk

K172708 is an FDA 510(k) clearance for the T2Bacteria Panel. Classified as Direct Blood Bacterial Nucleic Acid Detection System (product code QBX), Class II - Special Controls.

Submitted by T2biosystems, Inc. (Lexington, US). The FDA issued a Cleared decision on May 24, 2018 after a review of 258 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3960 - 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.

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Submission Details

510(k) Number K172708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2017
Decision Date May 24, 2018
Days to Decision 258 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
156d slower than avg
Panel avg: 102d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBX Direct Blood Bacterial Nucleic Acid Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3960
Definition Amplification, Detection And Identification Of Microbial Pathogens Directly From Whole Blood 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.