QStat Cartridge
510(k) K240045
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240045 | Date27 Mar 2024 | StatusActive |
Official records
- FDA 510(k) database K240045
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QFR
- FDA applicant
- Hemosonics, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 864.5430
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
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.