← Back to catalogue

QStat Cartridge

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240045

by Hemosonics LLC

Identifiers

510(k) Number
K240045 FDA 510(k)
FDA Product Code
QFR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5430 FDA 510(k)
Regulation Number
864.5430 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The QStat Cartridge is a multi-channel cartridge designed for use with the Quantra Hemostasis Analyzer, a coagulation system that measures whole blood viscoelastic properties. It employs Sonic Estimation of Elasticity via Resonance (SEER) sonorheometry, a patented ultrasound-based technology, to assess shear modulus dynamics during coagulation and clot lysis. This device supports diagnostic evaluation of a patient’s hemostatic function, providing quantitative insights into clot formation and stability. Classified under the FDA’s device classification system as a Class II medical device, it is intended for laboratory and perioperative settings where coagulation assessment is critical.

The QStat Cartridge is supplied as a single-use disposable component, requiring no sterilization or reprocessing. It is compatible with the Quantra Hemostasis Analyzer and operates within standard laboratory environments without MRI restrictions. Sizes or variants are not specified beyond its multi-channel design, and storage conditions align with standard medical device protocols for single-use cartridges. Its regulatory status includes FDA clearance via a 510(k) submission (K240045), affirming its compliance with U.S. medical device regulations for coagulation testing systems.

Frequently asked questions

What clinical settings is the QStat Cartridge intended for, and how does it differ from traditional coagulation tests?

The QStat Cartridge is designed for laboratory and perioperative environments where assessing a patient’s hemostatic function is critical. Unlike traditional coagulation tests, it uses Sonic Estimation of Elasticity via Resonance (SEER) sonorheometry, an ultrasound-based technology, to measure whole blood viscoelastic properties—providing real-time insights into clot formation, stability, and lysis dynamics. This makes it particularly useful in settings where rapid, detailed coagulation evaluation is needed, such as during surgery or in trauma care.

Is the QStat Cartridge reusable, or does it require sterilization between uses?

The QStat Cartridge is explicitly labeled as a single-use disposable component, meaning it is not intended for reuse or sterilization. This design eliminates the need for reprocessing and reduces the risk of contamination, aligning with standard practices for single-use medical devices in coagulation testing.

How does the QStat Cartridge integrate with the Quantra Hemostasis Analyzer, and are there any environmental restrictions?

The QStat Cartridge is compatible only with the Quantra Hemostasis Analyzer, functioning as a multi-channel disposable cartridge that interfaces directly with the system. There are no MRI restrictions mentioned, and it operates within standard laboratory environments without requiring specialized conditions. Storage follows typical protocols for single-use medical devices.

What regulatory pathway was followed for FDA clearance, and what does this mean for clinical adoption?

The QStat Cartridge received FDA clearance via a 510(k) submission (K240045), classified under the Hematology advisory committee and as a Class II device. The clearance was granted under a Special 510(k) determination, meaning it was deemed substantially equivalent to a predicate device. This pathway ensures compliance with U.S. medical device regulations for coagulation testing systems, validating its safety and effectiveness for clinical use in hemostasis evaluation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: QPlus® Cartridge & QStat® Cartridge | HemoSonics, QStat® Cartridge | HemoSonics, Quantra® Hemostasis System With Qstat® Cartridge

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hemosonics LLC
FDA Applicant
Hemosonics, LLC

Sources (1)

  • FDA 510(k) K240045 24 fields · synced Sep 20, 2026