Not Cleared Direct

DEN240035 - ConcizuTrace™ ELISA (FDA 510(k) Clearance)

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

DEN240035 · Randox Laboratories, Ltd. · Hematology device
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May 2025
Decision
325d
Days
Class 2
Risk

DEN240035 is an FDA 510(k) submission (not cleared) for the ConcizuTrace™ ELISA. Classified as Non-factor Replacement Product Test System (product code SES), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Not Cleared (DENG) decision on May 22, 2025 after a review of 325 days.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7298 - the FDA hematology 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 325 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number DEN240035 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 01, 2024
Decision Date May 22, 2025
Days to Decision 325 days
Submission Type Direct
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 113d · This submission: 325d
Pathway characteristics

Device Classification

Product Code SES Non-factor Replacement Product Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7298
Definition A Non-factor Replacement Product Test System Is A Prescription In Vitro Diagnostic Device Intended To Measure Non-factor Replacement Therapeutic Products That Are Indicated For Routine Prophylaxis To Prevent Or Reduce The Frequency Of Bleeding Episodes In Patients With Bleeding Disorders, Including Hemophilia, In Human Blood Specimens To Ensure Appropriate Therapy In Accordance With The Approved Non-factor Replacement Product Labeling.
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 Hematology devices follow this clearance model.