Not Cleared Direct

DEN230024 - Technozym ADAMTS13 Activity (FDA 510(k) Clearance)

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

DEN230024 · Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM · Hematology device
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Feb 2024
Decision
328d
Days
Class 2
Risk

DEN230024 is an FDA 510(k) submission (not cleared) for the Technozym ADAMTS13 Activity. Classified as Adamts13 Activity Test System (product code SAC), Class II - Special Controls.

Submitted by Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM (Vienna, AT). The FDA issued a Not Cleared (DENG) decision on February 28, 2024 after a review of 328 days.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7297 - 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 328 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 Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM devices

Submission Details

510(k) Number DEN230024 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 06, 2023
Decision Date February 28, 2024
Days to Decision 328 days
Submission Type Direct
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 113d · This submission: 328d
Pathway characteristics

Device Classification

Product Code SAC Adamts13 Activity Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7297
Definition An Adamts13 Activity Test System Is A Qualitative Or Quantitative In Vitro Diagnostic Device Intended To Detect Adamts13 Activity In Human Blood Specimens Collected From Patients Being Evaluated For Thrombotic Microangiopathy. This Device Is Indicated To Aid In The Diagnosis And Management Of Patients Being Evaluated For Thrombotic Thrombocytopenic Purpura In Conjunction With Other Clinical And Laboratory Findings.
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.