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Quantra QPlus System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201513

by Hemosonics LLC

Identifiers

510(k) Number
K201513 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 Quantra QPlus System is a coagulation system for the measurement of whole blood viscoelastic properties. It is classified as a Class II medical device under regulation number 864.5430 and has received FDA 510(k) clearance as substantially equivalent.

The system is supplied by Hemosonics LLC and is intended for use in hematology settings. It requires specific cartridges (QPlus® and QStat®) for operation and is used with the Quantra® Hemostasis Analyzer. Storage, handling, and use should follow the manufacturer's instructions for use as detailed in the device labeling.

Frequently asked questions

What is the Quantra QPlus System used for?

The Quantra QPlus System is used to measure whole blood viscoelastic properties, which helps assess coagulation status in hematology settings by analyzing how blood clots and dissolves under controlled conditions.

What components are required to operate the Quantra QPlus System?

The system requires specific QPlus® and QStat® cartridges for operation and is designed to work with the Quantra® Hemostasis Analyzer; these components are supplied by Hemosonics LLC and must be used together as specified in the manufacturer’s instructions for use.

Is the Quantra QPlus System intended for single-use or reusable components?

The Quantra QPlus System itself is a reusable analyzer platform, but the QPlus® and QStat® cartridges are single-use disposables; the system requires these cartridges for each test, and reuse of cartridges is not permitted per manufacturer labeling.

How should the Quantra QPlus System and its components be stored?

Storage, handling, and use of the Quantra QPlus System and its associated cartridges must follow the manufacturer's instructions for use as detailed in the device labeling to ensure proper performance and safety.

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, Discover the Quantra® Hemostasis System | HemoSonics, HemoSonics' Quantra® Hemostasis System, HemoSonics receives clearance to expand Quantra Hemostasis System to ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hemosonics LLC
FDA Applicant
Hemosonics, LLC

Sources (1)

  • FDA 510(k) K201513 24 fields · synced Sep 25, 2026