Cleared Special

K240045 - QStat Cartridge (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway.

K240045 · Hemosonics, LLC · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
82d
Days
Class 2
Risk

K240045 is an FDA 510(k) clearance for the QStat Cartridge. Classified as Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (product code QFR), Class II - Special Controls.

Submitted by Hemosonics, LLC (Durham, US). The FDA issued a Cleared decision on March 27, 2024 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5430 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hemosonics, LLC devices

Submission Details

510(k) Number K240045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2024
Decision Date March 27, 2024
Days to Decision 82 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 113d · This submission: 82d
Pathway characteristics
Modification to existing cleared device.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Hematology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06025708 Completed Observational Industry-sponsored

Quantra QStat Sample Type Comparison

Impact of Sample Type on the Performance of the Quantra QStat System

25
Patients (actual)
1
Site
Condition studied Coagulation Defect; Bleeding
Eligibility All sexes · 18 Years+
Sponsor HemoSonics LLC (industry)
Started 2023-09-11 → Primary completion 2024-01-05 → Completed 2024-03-01
Primary outcome
Comparison of QStat Clot time (CT) in arterial and venous samples
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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 K240045.
Quantra QStat Cartridge
K251404 · Hemosonics, LLC · Aug 2025
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