HemoSonics, LLC (a Stago Group Company)
400 Preston Ave.
#250
Charlottesville, VA 22903
General Information: contact@hemosonics.com or 1-800-280-5589 |
www.HemoSonics.com |
COMPANY DESCRIPTION:
HemoSonics is revolutionizing point-of-care bleeding management by bringing you the Quantra® QPlus® System - a novel, closed-cartridge viscoelastic (VET) assay based on an innovative ultrasound technology.
When time is critical, the Quantra System offers rapid, precise, and easy to interpret coagulation results that enable clinicians to make quick and informed decisions at the point of care (POC). The Quantra is the first whole-blood VET coagulation analyzer intended for use at the POC (DEN180017 - FDA).
The Quantra Hemostasis Analyzer and its initial QPlus cartridge provide information on the coagulation status of samples from perioperative patients 18 or older at the point-of-care (such as OR or ICU). QPlus Cartridge is currently indicated for use in cardiovascular and major orthopedic surgeries.
The Quantra is both CE marked and cleared through the FDA de novo process for sale in the USA. |
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TEST KIT REQUIREMENTS:
| Test Kit Name: |
QPlus Cartridge |
| CLIA Classification: |
Class II |
| Analytes performed on this device: |
The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer. |
| CPT Code associated with each analyte: |
There is no CPT for the QPlus cartridge, but procedures are reimbursed as a whole under DRG. |
| Test methodology: |
Sonic Estimation of elasticity via resonance (SEER) Sonorheometry. |
| Sample volume: |
Undiluted venous whole blood: 2.7 mL; 3.2% citrated venous whole blood: 3 mL |
| Time to result: |
Typically15 minutes or less. |
| Units in which the test is reported: |
- Clot time (CT), Heparinase clot time (CTH): seconds.
- Clot time ratio (CTR): no units (ratio of the above parameters).
- Clot Stiffness (CS), Fibrinogen contribution to clot stiffness (FCS) and Platelet contribution to clot stiffness (PCS): hectoPascals.
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INSTRUMENT INFORMATION:
| Instrument Name: |
Quantra Hemostasis Analyzer |
| Model Name: |
HS-002 |
| CLIA Classification |
Class II |
| Size and Weight: |
12 x 14 x 19.25 inches (30 x 36 x 49 cm) and 36 lbs. (16.5 kg) |
| Specifications: |
- Heat output: 75 Watts
- Operating Temperature: 15-32°C
- Relative humidity: 20-85%
- Altitude: Sea level to 1800 m
- Location: Flat level surface. Indoor use only.
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| Data Transfer Capability: |
Yes |
| Features: |
Determines clot time and stiffness coagulation parameters to allow more informed decisions on bleeding management. |
| Test Menu (Analytes that can be performed on instrument): |
Provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer. |
| CPT code for each analyte: |
Code 85396 is generally used for whole blood viscoelastic coagulation tests. However, if done in-patient, reimbursement is based on a DRG model. |
| Test Methodology: |
Sonic Estimation of Elasticity via Resonance (SEER) sonorheometry |
| Units in which the test is reported: |
- Clot time (CT), Heparinase clot time (CTH): seconds.
- Clot time ratio (CTR): no units (ratio of the above parameters).
- Clot Stiffness (CS), Fibrinogen contribution to clot stiffness (FCS) and Platelet contribution to clot stiffness (PCS): hectoPascals.
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SOFTWARE INFORMATION:
| Name of Software package: |
Quantra Instrument Software |
| Current Version # availability: |
1.6.15.3 |
| Included download capability: |
Yes |
| Operating system capability: |
1.0.26 |
| Administration features: |
Yes – External QC History, Event Logs, Users, Cartridge, Lots, Instrument, Remote Systems, Software Update |
| User features: |
Yes – Running control and whole blood samples and Viewing Run History |
| QC features: |
Yes – Internal and external QC; Internal QC is performed upon start-up, each time a cartridge is inserted into the instrument, and every 8 hours to ensure the main system components are working properly (docking, fluidics, ultrasound, heating and system). External QC is recommended (1) to qualify a new cartridge lot, (2) to qualify a new control lot, (3) after instrument service, and (4) according to site-specific quality control plans, determined from ICQP. The are 2 levels of external QC, a normal and an abnormal sample. |
| Instrument management features: |
Included as Admin features |
| Inventory Control features: |
No |
| Reporting features: |
Yes |
| Install base (# completed) |
Please inquire: contact@hemosonics.com |
| Export capability: |
Can export QC results to a USB drive as well as instrument LIS and POC connectivity capabilities (Telcor and RALS) |
| LIS Interface capability: |
Yes |
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Scripted: Currently, the information exchanged between the Quantra instrument and the Laboratory Information system (LIS) consists of the test result message that is pushed from the Quantra instrument to the LIS. This transfer data protocol conforms to the LIS02-A2 standard. |
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Direct interface (HL7, ASTM): Quantra does not communicate via to HL7, but when connected to a Middleware solution such as RALS or Telcor, the Middleware will communicate via HL7 sending results to the system. |
| LIS Installs: |
Quantra connected to LIS system through both RALS and TELCOR to Epic system in the USA now. |
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