Not Cleared Direct

DEN140019 - T2CANDIDA AND T2DX INSTRUMENT (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN140019 · T2biosystems, Inc. · Microbiology device
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Sep 2014
Decision
118d
Days
Class 2
Risk

DEN140019 is an FDA 510(k) submission (not cleared) for the T2CANDIDA AND T2DX INSTRUMENT. Classified as Candida Species Nucleic Acid Detection System (product code PII), Class II - Special Controls.

Submitted by T2biosystems, Inc. (Lexington, US). The FDA issued a Not Cleared (DENG) decision on September 22, 2014 after a review of 118 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all T2biosystems, Inc. devices

Submission Details

510(k) Number DEN140019 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 27, 2014
Decision Date September 22, 2014
Days to Decision 118 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 102d · This submission: 118d
Pathway characteristics

Device Classification

Product Code PII Candida Species Nucleic Acid Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3960
Definition The Candida Species Nucleic Acid Detection System Is A Qualitative Panel For The Direct Detection Of Candida Species In Whole Blood Specimens From Patients With Symptoms Of, Or Medical Conditions Predisposing The Patients To, Invasive Fungal Infections. The Test Is Indicated For The Presumptive Diagnosis Of Candidemia. The Test Is Performed Independent Of Blood Culture. Concomitant Blood Cultures Are Necessary To Recover Organisms For Susceptibility Testing Or Further Identification.
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.