Not Cleared Direct

DEN200067 - INNOVANCE VWF Ac (FDA 510(k) Clearance)

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

DEN200067 · Siemens Healthcare Diagnostics Products GmbH · Hematology device
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Sep 2022
Decision
701d
Days
Class 2
Risk

DEN200067 is an FDA 510(k) submission (not cleared) for the INNOVANCE VWF Ac. Classified as Von Willebrand Factor Assay (product code QTY), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Not Cleared (DENG) decision on September 29, 2022 after a review of 701 days.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7293 - 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 701 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.

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Submission Details

510(k) Number DEN200067 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 28, 2020
Decision Date September 29, 2022
Days to Decision 701 days
Submission Type Direct
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
588d slower than avg
Panel avg: 113d · This submission: 701d
Pathway characteristics

Device Classification

Product Code QTY Von Willebrand Factor Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7293
Definition A Von Willebrand Factor Assay Is A Prescription Device Intended For The Measurement Of Von Willebrand Factor Activity Or Von Willebrand Factor Size Distribution In Human Plasma.
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.