(29 days)
Not Found
No
The document describes a system based on ultrasound technology (SEER Sonorheometry) to measure blood coagulation parameters. It mentions measured and calculated parameters but does not include any terms or descriptions indicative of AI or ML algorithms being used for analysis, interpretation, or prediction. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an in vitro diagnostic (IVD) system used to evaluate blood coagulation in perioperative patients, which provides diagnostic information rather than directly treating a condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states, "The Quantra® QPlus® System is intended for in vitro diagnostic use." It further details its use for "the evaluation of blood coagulation in perioperative patients... to assess possible hypocoagulable and hypercoagulable conditions."
No
The device description explicitly states that the system consists of an instrument (Quantra Hemostasis Analyzer), a single-use disposable cartridge (QPlus Cartridge), and external quality control materials (QPlus Controls), all of which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Quantra OPlus System is intended for in vitro diagnostic use."
- Purpose: The system is designed to evaluate the viscoelastic properties of whole blood to assess possible hypocoagulable and hypercoagulable conditions. This is a diagnostic purpose, providing information about a patient's health status.
- Sample Type: It uses a "3.2% citrated venous or arterial whole blood sample," which is a biological sample taken from the human body.
- Testing Location: It is intended for use "at the point-of-care and in clinical laboratories," which are typical settings for in vitro diagnostic testing.
- Parameters Measured: The system measures and calculates parameters related to blood coagulation (Clot Time, Clot Stiffness, etc.), which are used to diagnose or monitor medical conditions.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantra® QPlus® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quality Controls Level 1 and 2. The Quantra OPlus System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous or arterial 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.
The system is intended to be used 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 with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Time Ratio (CTR).
The Quantra QPlus System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure. Results obtained with the Quantra QPlus System should not be the sole basis for patient diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
QFR
Device Description
The Quantra QPlus System consists of an instrument (the Quantra Hemostasis Analyzer), a single-use disposable cartridge (QPlus Cartridge), and external quality control materials (QPlus Controls). The OPlus System is intended for use with patients 18 years or older by professionals in a hospital setting (point of care or laboratory). The measurements are performed in four test channels of the disposable cartridge.
The QPlus Cartridge is a multichannel disposable cartridge which enables four independent measurements to be performed in parallel with different sets of reagents without the need for any reagent preparation or controlled pipetting. The cartridge utilizes a citrated evacuated blood collection tube filled with a patient whole blood sample The proprietary technology SEER Sonorheometry measures the evolution of shear modulus (i.e., clot stiffness) in all four channels as a function of time.
Clot times and clot stiffness values obtained from the measurements performed by the QPlus Cartridge are combined to form parameters that depict the functional status of the patient's coagulation system. Four (4) of the parameters are measured and two (2) are calculated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
age 18 years and older
Intended User / Care Setting
trained professionals at the point-of-care and in clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5430 Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
(a)
Identification. A coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in perioperative patients, as an aid in the assessment of coagulopathies when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include detailed documentation of, and results from, the following:
(i) A study assessing precision using protocols determined to be acceptable by FDA, to cover the measurement range for each reported parameter (test output). Testing must include native specimens with coagulation profiles representative of the intended use population. In order to cover the measuring range, testing may include a limited number of contrived specimens, not to exceed 10 to 20 percent, or as otherwise deemed appropriate by FDA. The contrived specimens must be prepared to resemble clinical specimens. This testing must evaluate repeatability and reproducibility and provide assessments of within-run, within-day, between-run, between-day, between-reagent lot, between-instrument, between-site, and between-operator precision, as applicable to the system;
(ii) Studies that demonstrate the performance of each parameter (test output) throughout the claimed measurement range, to include linearity studies or dose-response studies, as applicable to the parameter (test output);
(iii) Potential interferent study that includes evaluation of hemolyzed and lipemic samples as potential interferents; exogenous and endogenous interferents associated with each patient population intended for use with the device, and which might be expected to affect assay performance, must be evaluated; and potential interferents that are specific for, or related to, the technology or methodology of the device. Evaluation of all potential interferents must be performed using a protocol determined to be acceptable to the FDA (
e.g., an FDA-recognized standard) and include both normal and abnormal specimens covering coagulation profiles representative of the intended use population;(iv) A study that evaluates specimen stability under the intended conditions for specimen collection, handling, and storage, using samples that cover the coagulation profiles representative of the intended use population, and using protocols determined to be acceptable by FDA;
(v) A multisite clinical study, determined to be acceptable by FDA, demonstrating performance, relative to clinically relevant and clinically validated laboratory test(s) for each parameter (test output). Further, the study must meet all of the following criteria:
(A) The study must be performed in the intended use population and include representation from all patient populations for whom the device is intended to be used. Potential endogenous and exogenous interferents for each target patient population must be evaluated or known prior to the study;
(B) The study must be conducted at a minimum of three external sites representative of the intended use setting by the intended operators;
(C) Test samples must be collected at time intervals relevant to the device's use in the intended use population;
(D) Clinical specimens, which cover coagulation profiles representative of the intended use population, must be evaluated at each of the three clinical sites in the study;
(E) Analysis of the concordance of clinical interpretation of patient coagulation status made from individual test parameter (test output) results as compared to clinical interpretation of coagulation status from a clinically relevant laboratory test or tests (
e.g., a comparative viscoelastic device or standard laboratory tests) must be conducted; and(F) Expected (reference) values for each parameter (test output) must be demonstrated by testing a statistically appropriate number of samples from apparently healthy normal individuals;
(vi) For a device with a user interface that has information that needs to be interpreted by the user in correctly using the device to achieve the intended test results or a device that does not provide a final output that is a comprehensive interpretation of all parameter (test output) results, a study evaluating the ability of device users to correctly interpret results;
(vii) For any device indicated to guide blood product use, a clinical outcome study determined to be acceptable by FDA that specifically validates the device's indicated use in guiding blood product use; and
(viii) For any device indicated to guide use of medication, a clinical outcome study determined to be acceptable by FDA that specifically validates the device's indicated use in guiding use of medication.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A summary of results from the study required by paragraph (b)(1)(i) of this section, including repeatability, reproducibility, and assessments of within-run, within-day, between-run, between-day, between-reagent lot, between-instrument, between-site, and between-operator precision, as applicable to the system.
(ii) The claimed measurement range of each parameter (test output), as supported by demonstrated performance of the parameter (test output) throughout the claimed measurement range, including studies required by paragraphs (b)(1)(i) through (iii) and (v) of this section, and, if applicable, paragraphs (b)(1)(vii) and (viii) of this section.
(iii) Identification of known interferents, including all endogenous, exogenous, technology-specific, and patient population-specific interferents, specific to each parameter (test output). The information must include the concentration(s) or level(s) at which interference was found to occur and the concentration range or levels at which interference was not found to occur.
(iv) Information regarding the multisite clinical study required by paragraph (b)(1)(v) of this section, including:
(A) Each patient population evaluated;
(B) Each intended use setting and the operators;
(C) A summary of the results, including the concordance analysis to clinically relevant laboratory test(s); and
(D) Demonstrated expected (reference) values for each parameter (test output).
(3) The labeling required under § 809.10 of this chapter must include the following:
(i) A limiting statement that the result(s) from the device is(are) not intended to be used as the sole basis for a patient diagnosis.
(ii) Unless appropriate clinical outcome studies are done in accordance with paragraph (b)(1)(vii) of this section that specifically validate an indication for the device's use in guiding blood product use, a limiting statement that the device has not been evaluated to guide blood product use.
(iii) Unless appropriate clinical outcome studies are done in accordance with paragraph (b)(1)(viii) of this section that specifically validate an indication for the device's use in guiding use of medication, a limiting statement that the device has not been evaluated to guide use of medication.
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December 13, 2022
HemoSonics, LLC Deborah Winegar Vice-President, Clinical Affairs 4020 Stirrup Creek Drive. Suite 105 Durham, North Carolina 27703
Re: K223433
Trade/Device Name: Quantra QPlus System Regulation Number: 21 CFR 864.5430 Regulation Name: Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients Regulatory Class: Class II Product Code: OFR Dated: November 14, 2022 Received: November 14, 2022
Dear Deborah Winegar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Min Wu-S" in a large, sans-serif font. The text is black and is set against a white background. The letters are evenly spaced and the text is easy to read. The image is simple and straightforward, with no other elements present.
Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name QPlus® Cartridge
Indications for Use (Describe)
The Quantra® QPlus® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quality Controls Level 1 and 2. The Quantra OPlus System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous or arterial 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.
The system is intended to be used 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 with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Time Ratio (CTR).
The Quantra QPlus System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure. Results obtained with the Quantra QPlus System should not be the sole basis for patient diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 5. SPECIAL 510(K) SUMMARY
A. APPLICANT INFORMATION
| Submission Date: | November 14, 2022 |
|---|---|
| Submitter Information: | HemoSonics, LLC |
| 4020 Stirrup Creek Drive, Suite 105 | |
| Durham, NC 27703 | |
| Phone: 919-244-6990 | |
| Contact Person: | Deborah Winegar, PhD |
| Email: dwinegar@hemosonics.com | |
| Phone: 919-244-6990 |
B. PROPRIETARY AND ESTABLISHED NAMES
Quantra® QPlus® System
C. REGULATORY INFORMATION
| Trade/Device Name: | Quantra QPlus System |
|---|---|
| Regulation Number: | 21 CFR 864.5430 |
| Regulation Name: | Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients |
| Regulatory Classification: | Class II |
| Product Code: | QFR |
D. PURPOSE OF SUBMISSION
To add a sample matrix to the intended use and indications for use statement for the QPlus Cartridge. This change does not alter the device's fundamental scientific technology.
E. MEASURAND
The combination of clot time and clot stiffness parameters measured from the four channels of the cartridge provides information about the functional role of coagulation factors, fibrinogen, and platelets in the sample.
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F. TYPE OF TEST
The Quantra QPlus System is an in vitro diagnostic device designed to assess a patient's coagulation system by measuring the viscoelastic properties of a blood sample during clot formation in surgical and intensive care settings. The system consists of the Quantra Hemostasis Analyzer (instrument), a single-use disposable cartridge, (OPlus Cartridge) and Quantra Quality Controls (external Quality Control materials).
G. INTENDED USE AND INDICATIONS FOR USE STATEMENT
The Quantra® OPlus® System is composed of the Quantra Hemostasis Analyzer, OPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra QPlus System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The QPlus Cartridge is a multi-channel cartridge that provides semiquantitative indications of the coagulation state of a 3.2% citrated venous or arterial 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.
The system is intended to be used 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 Time with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Time Ratio (CTR).
The Quantra QPlus System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure. Results obtained with the Quantra OPlus System should not be the sole basis for patient diagnosis.
H. DEVICE DESCRIPTION
The Quantra QPlus System consists of an instrument (the Quantra Hemostasis Analyzer), a single-use disposable cartridge (QPlus Cartridge), and external quality control materials (QPlus Controls). The OPlus System is intended for use with patients 18 years or older by professionals in a hospital setting (point of care or laboratory). The measurements are performed in four test channels of the disposable cartridge.
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Image /page/5/Picture/0 description: The image shows the logo for Hemosonics. The logo consists of a red blood drop with sound waves emanating from it on the left, followed by the word "HEMOSONICS" in black, sans-serif font. The logo is simple and modern, and the use of red and black gives it a bold and professional look.
The QPlus Cartridge is a multichannel disposable cartridge which enables four independent measurements to be performed in parallel with different sets of reagents without the need for any reagent preparation or controlled pipetting. The cartridge utilizes a citrated evacuated blood collection tube filled with a patient whole blood sample The proprietary technology SEER Sonorheometry measures the evolution of shear modulus (i.e., clot stiffness) in all four channels as a function of time.
Clot times and clot stiffness values obtained from the measurements performed by the QPlus Cartridge are combined to form parameters that depict the functional status of the patient's coagulation system. Four (4) of the parameters are measured and two (2) are calculated. The parameters are summarized in Table 5-1.
| Channel | Reagents | Measurement | Description | Units | Reportable
Range |
|------------|----------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------|-----------------------|---------------------|
| 1 | Kaolin, calcium buffers
&stabilizers | Clot Time (CT) | Clot time in citrated
whole blood | sec | 60 to 480 |
| 2 | Kaolin, heparinase I, calcium
buffers & stabilizers | Heparinase Clot
Time (CTH) | Clot time in citrated
whole blood with heparin
neutralization | sec | 60 to 480 |
| 3 | Thromboplastin, polybrene,
calcium, buffers & stabilizers | Clot Stiffness (CS) | Stiffness of the whole
blood clot | hPa
(hectopascals) | 2 to 65 |
| 4 | Thromboplastin, polybrene,
abciximab, calcium, buffers
& stabilizers | Fibrinogen
Contribution (FCS) | Contribution of
functional fibrinogen to
clot stiffness | hPa
(hectopascals) | 0.2 to 30 |
| Calculated | Calculated by subtracting
FCS from CS | Platelet
Contribution (PCS) | Contribution of platelet
activity to clot stiffness | hPa
(hectopascals) | 2 to 50 |
| Calculated | Calculated ratio of CT over
CTH | Clot Time Ratio
(CTR) | Assessment of residual
heparin anticoagulation | Unitless | 0.8 to 4 |
Table 5-1. QPlus Cartridge Output Parameters
I. DEVICE MODIFICATION DESCRIPTION
The Quantra System was previously cleared under DEN180017 with a sample matrix claim of venous whole blood. HemoSonics is submitting this Special 510(k) to demonstrate the equivalency of arterial and venous whole blood samples analyzed on the Quantra Hemostasis Analyzer with the QPlus Cartridge in order to expand the sample matrices accepted on this system.
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J. SUBSTANTIAL EQUIVALENCE INFORMATION
Predicate Device Name: Quantra Plus System
Predicate 510(k) Number: DEN180017
Comparison with the Predicate:
Table 5-2 provides an overall comparison of the modified Quantra QPlus System with the previously cleared Quantra QPlus System.
| Modified Device | Predicate Device | |
|---|---|---|
| Quantra System | Quantra System | |
| (Subject of Special 510(k)) | (DEN180017) | |
| Similarities | ||
| Manufacturer | HemoSonics, LLC | Same |
| Trade Name | Quantra QPlus System | Same |
| Common Name | Whole Blood Hemostasis System | Same |
| Classification Name | Coagulation system for the measurement | |
| of whole blood viscoelastic properties in | ||
| perioperative patients | Same | |
| Regulation Number | 21 CFR 864.5430 | Same |
| Product Code | QFR | Same |
| Device Class | II | Same |
| Location of Use | Point of care and laboratory settings | Same |
| Disposables | QPlus Cartridge (multichannel cartridge) | |
| QStat Cartridge (multichannel cartridge) | ||
| Quantra Quality Controls (Level 1 and | ||
| Level 2) | Same | |
| Analyzer Hardware | Quantra Hemostasis Analyzer HS-002 | Same |
| Analyzer Software | Ver 2.1.37 | Same |
| Differences | ||
| Indications for use | The Quantra® QPlus® System is | |
| composed of the Quantra Hemostasis | ||
| Analyzer, QPlus Cartridge, QStat | ||
| Cartridge, and Quantra Quality Controls | ||
| Level 1 and 2. The Quantra System is | ||
| intended for in vitro diagnostic use. | ||
| The Quantra Hemostasis Analyzer uses | ||
| Sonic Estimation of Elasticity via | ||
| Resonance (SEER) Sonorheometry, an | ||
| ultrasound-based technology, to measure | ||
| the shear modulus of whole blood during | ||
| coagulation. The cartridges are multi- | ||
| channel and provides semi-quantitative | ||
| indications of the coagulation state of a | The Quantra® QPlus® System is composed | |
| of the Quantra Hemostasis Analyzer, | ||
| QPlus Cartridge, QStat Cartridge, and | ||
| Quantra Quality Controls Level 1 and 2. | ||
| The Quantra System is intended for in | ||
| vitro diagnostic use. | ||
| The Quantra Hemostasis Analyzer uses | ||
| Sonic Estimation of Elasticity via | ||
| Resonance (SEER) Sonorheometry, an | ||
| ultrasound-based technology, to measure | ||
| the shear modulus of whole blood during | ||
| coagulation. The cartridges are multi- | ||
| channel and provides semi-quantitative | ||
| indications of the coagulation state of a |
Table 5-2: Comparison between DEN180017 and Modified Quantra System
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| Modified Device | Predicate Device | |
|---|---|---|
| Quantra System | Quantra System | |
| (Subject of Special 510(k)) | (DEN180017) | |
| 3.2% citrated venous or arterial whole | ||
| blood sample. Cartridges include tests to | ||
| assess coagulation characteristics via the | ||
| intrinsic pathway, via the extrinsic | ||
| pathway, and includes tests with a | ||
| heparin neutralizer. | ||
| The system is intended to be used by | ||
| trained professionals at the point-of-care | ||
| and in clinical laboratories to evaluate | ||
| the viscoelastic properties of whole | ||
| blood. | ||
| The Quantra System is indicated for the | ||
| evaluation of blood coagulation in | ||
| perioperative patients age 18 years and | ||
| older to assess possible hypocoagulable | ||
| and hypercoagulable conditions in | ||
| cardiovascular or major orthopedic | ||
| surgeries before, during, and following | ||
| the procedure. | ||
| Results obtained with the Quantra | ||
| System should not be the sole basis for | ||
| patient diagnosis. | 3.2% citrated venous whole blood sample. | |
| Cartridges include tests to assess | ||
| coagulation characteristics via the intrinsic | ||
| pathway, via the extrinsic pathway, and | ||
| includes tests with a heparin neutralizer. | ||
| The system is intended to be used by | ||
| trained professionals at the point-of-care | ||
| and in clinical laboratories to evaluate the | ||
| viscoelastic properties of whole blood. | ||
| The Quantra System is indicated for the | ||
| evaluation of blood coagulation in | ||
| perioperative patients age 18 years and | ||
| older to assess possible hypocoagulable | ||
| and hypercoagulable conditions in | ||
| cardiovascular or major orthopedic | ||
| surgeries before, during, and following the | ||
| procedure. | ||
| Results obtained with the Quantra System | ||
| should not be the sole basis for patient | ||
| diagnosis. | ||
| Sample Type(s) | Arterial and venous whole blood | Venous whole blood |