Not Cleared Direct

DEN180017 - Quantra Hemostasis Analyzer, QPlus Cartridge (FDA 510(k) Clearance)

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

DEN180017 · Hemosonics, LLC · Hematology device
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Mar 2019
Decision
344d
Days
Class 2
Risk

DEN180017 is an FDA 510(k) submission (not cleared) for the Quantra Hemostasis Analyzer, QPlus Cartridge. Classified as Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (product code QFR), Class II - Special Controls.

Submitted by Hemosonics, LLC (Charlottesville, US). The FDA issued a Not Cleared (DENG) decision on March 12, 2019 after a review of 344 days.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5430 - 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 344 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 Hemosonics, LLC devices

Submission Details

510(k) Number DEN180017 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 02, 2018
Decision Date March 12, 2019
Days to Decision 344 days
Submission Type Direct
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 113d · This submission: 344d
Pathway characteristics

Device Classification

Product Code QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5430
Definition A Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties Is An In Vitro Diagnostic Device Used To Evaluate Blood Coagulation, Fibrinolysis, Or Both, In Patients.
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.

Regulatory Peers - QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

All 7
Devices cleared under the same product code (QFR) and FDA review panel - the closest regulatory comparables to DEN180017.
Quantra QStat Cartridge
K251404 · Hemosonics, LLC · Aug 2025
QStat Cartridge
K240045 · Hemosonics, LLC · Mar 2024
Quantra Hemostasis Analyzer
K232215 · Hemosonics, LLC · Aug 2023
Quantra Hemostasis Analyzer
K230461 · Hemosonics, LLC · Mar 2023
Quantra QPlus System
K223433 · Hemosonics, LLC · Dec 2022
QStat Cartridge
K213917 · Hemosonics, LLC · Nov 2022