# K251404: Quantra QStat Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Hemosonics, LLC
- Decided: Aug 25, 2025 after 111 days
- Product code: QFR (Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties)
- Device class: 2
- Regulation: 21 CFR 864.5430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002177 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240045: QStat Cartridge, Hemosonics, LLC (2024) Summary page 7.

## Indications for use
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous or arterial whole blood sample using the Quantra Hemostasis Analyzer. The QStat Cartridge includes tests to assess coagulation via the intrinsic and extrinsic pathways and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is intended for in vitro diagnostic use by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL). The QStat Cartridge is indicated for the evaluation of blood coagulation and clot lysis in patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in trauma, liver transplantation, and peripartum obstetric procedures. Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis. For prescription use only.

Source page: https://510kreport.com/device/K251404
Methodology: https://510kreport.com/methodology