Not Cleared Direct

DEN200001 - Cell-Free DNA BCT (FDA 510(k) Clearance)

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

DEN200001 · Streck, Inc. · Chemistry device
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Aug 2020
Decision
210d
Days
Class 2
Risk

DEN200001 is an FDA 510(k) submission (not cleared) for the Cell-Free DNA BCT. Classified as Blood Collection Device For Cell-free Nucleic Acid (product code QMA), Class II - Special Controls.

Submitted by Streck, Inc. (La Vista, US). The FDA issued a Not Cleared (DENG) decision on August 7, 2020 after a review of 210 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1676 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework.

View all Streck, Inc. devices

Submission Details

510(k) Number DEN200001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 10, 2020
Decision Date August 07, 2020
Days to Decision 210 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 88d · This submission: 210d
Pathway characteristics

Device Classification

Product Code QMA Blood Collection Device For Cell-free Nucleic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1676
Definition A Blood Collection Device For Cell-free Nucleic Acids Is A Device Intended For Medical Purposes To Collect, Store, Transport, And Handle Blood Specimens And To Stabilize And Isolate Cell-free Nucleic Acid Components Prior To Further Testing.
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 Chemistry devices follow this clearance model.