Not Cleared Direct

DEN210056 - Procise IFX (FDA 510(k) Clearance)

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

DEN210056 · Procisedx, Inc. · Toxicology device
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Sep 2023
Decision
660d
Days
Class 2
Risk

DEN210056 is an FDA 510(k) submission (not cleared) for the Procise IFX. Classified as Infliximab Test System (product code QXT), Class II - Special Controls.

Submitted by Procisedx, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on September 29, 2023 after a review of 660 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3115 - the FDA toxicology 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: Regulatory edge-case submission. High predicate equivalence gap. With 660 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Procisedx, Inc. devices

Submission Details

510(k) Number DEN210056 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 08, 2021
Decision Date September 29, 2023
Days to Decision 660 days
Submission Type Direct
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
573d slower than avg
Panel avg: 87d · This submission: 660d
Pathway characteristics

Device Classification

Product Code QXT Infliximab Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3115
Definition An Infliximab Test System Intended For The Measurement Of An Infliximab As An Aid In The Management Of Patients With Crohn’s Disease Or Ulcerative Colitis.
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 Toxicology devices follow this clearance model.