(29 days)
No
The summary describes an ultrasound-based technology for measuring blood coagulation properties and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) system used to evaluate blood coagulation, not to directly treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Quantra System is intended for in vitro diagnostic use."
No
The device description explicitly states that the system is composed of a "Quantra Hemostasis Analyzer," "QPlus Cartridge," and "Quantra Quality Controls Level 1 and 2," indicating the presence of hardware components in addition to any potential software.
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 System is intended for in vitro diagnostic use."
- Nature of the Device: The device analyzes whole blood samples in vitro (outside of the body) to provide information about the patient's coagulation state. This is a core characteristic of an IVD.
- Purpose: The system is used by trained professionals to evaluate the viscoelastic properties of whole blood and assess possible hypocoagulable and hypercoagulable conditions, which are diagnostic purposes.
- Components: The system includes cartridges and quality controls, which are typical components of IVD systems used for testing biological samples.
N/A
Intended Use / Indications for Use
The Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus 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 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 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 QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, during, the procedure.
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 whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is indicated for use in trauma and liver transplantation procedures.
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. Results obtained with the Quantra System should not be the sole basis for patient diagnosis.
Product codes
OFR
Device Description
The Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. 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 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 whole blood sample. 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.
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
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)
Interfering Substance Testing:
The interference study tested substances for which "Not Computable" results due to delayed clot initiation were reported for CS and/or FCS in the studies conducted in support of DEN180017. Similar protocols, acceptance criteria, and sample sizes were utilized. Testing was limited to dabigatran and rivaroxaban as these were the only direct-acting oral anticoagulants that generated "Not Computable" results due to delayed clot initiation for CS and/or FCS. Rivaroxaban and dabigatran demonstrated a dose response effect of clot time parameter prolongation and clot stiffness parameter reduction.
Precision Testing: Whole Blood Repeatability Study:
This study evaluated whole blood repeatability and assessed the precision of the modified device using whole blood samples across multiple instruments, operators, and cartridge lots. The study was performed with contrived whole blood requiring an assay time within the extended maximum assay time. Total imprecision, including variability between operators, cartridge lots, instruments, and test replicates, ranged from 5.8% to 14.4% CV.
Clinical Performance Testing:
Clinical samples were collected from adult cardiac surgery patients undergoing treatment in the intensive care unit at a single medical center. Samples were analyzed on the modified Quantra System with the QPlus Cartridge in parallel with testing on the ROTEM delta (Werfen, Bedford, MA). Correlation analyses were performed to compare measurements obtained with the QPlus Cartridge to comparable measurements obtained with the ROTEM delta CT vs INTEM CT, CS vs EXTEM A20, FCS vs FIBTEM A20 and PCS vs PLATEM (defined as EXTEM A20 - FIBTEM A20). Linear regression summary results for all comparisons showed r > 0.8 (0.82 to 0.94) for the correlation analysis, demonstrating a strong correlation of QPlus parameters to corresponding ROTEM delta parameters.
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.
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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August 24, 2023
HemoSonics, LLC Debbie Winegar Vice-President, Clinical Affairs 4020 Stirrup Creek Drive. Suite 105 Durham, North Carolina 27703
Re: K232215
Trade/Device Name: Quantra Hemostasis Analyzer 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: July 26, 2023 Received: July 26, 2023
Dear Debbie 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 appears to be the main subject of the image. The background is white, with a faint, light blue watermark that is partially visible behind the text.
Min Wu, Ph.D. 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) K232215
Device Name Quantra Hemostasis Analyzer
Indications for Use (Describe)
The Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus 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 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 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 QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, during, the procedure.
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 whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is indicated for use in trauma and liver transplantation procedures.
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. Results obtained with the Quantra 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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510(K) SUMMARY
A. APPLICANT INFORMATION
| Submission Date: | July 26, 2023 |
|---|---|
| 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® Plus System, Quantra Hemostasis Analyzer, Quantra QPlus Cartridge
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 implement a software modification to the Quantra Hemostasis Analyzer that will extend the QPlus Cartridge maximum assay time for reporting clot stiffness results from 15 minutes to 25 minutes. This change does not affect the device's intended use nor alter the device's fundamental scientific technology. There were no changes to the reagents, algorithms used to calculate results, reportable ranges of the output parameters, user interface, or results display.
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 OPlus 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.
G. INTENDED USE AND INDICATIONS FOR USE STATEMENT
The intended use/indications for use have not been modified from the intended use/indications for use cleared in K230461.
The Quantra® System is composed of the Quantra Hemostasis Analyzer. OPlus Cartridge. OStat 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 system is intended to be used by trained professionals at the point-ofcare and in clinical laboratories to evaluate the viscoelastic properties of whole blood.
The OPlus 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 QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, during, and following the procedure.
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 whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics. The OStat Cartridge is indicated for use in trauma and liver transplantation procedures.
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. Results obtained with the Quantra System should not be the sole basis for patient diagnosis.
H. DEVICE MODIFICATION DESCRIPTION
HemoSonics is submitting this Special 510(k) to implement a software modification to the Quantra Hemostasis Analyzer that will extend the QPlus Cartridge maximum assay time for reporting clot stiffness results from 15 minutes to 25 minutes.
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I. SUBSTANTIAL EQUIVALENCE INFORMATION
Predicate Device Name: Quantra QPlus System
K230461 Predicate 510(k) Number:
Comparison with the Predicate:
Table 7-1 provides an overall comparison of the modified Quantra System with the previously cleared Quantra System.
Table 7-1: Comparison between the Modified Quantra Hemostasis Analyzer and QPlus Cartridge and the Predicate Device (K230461)
| Modified Device | Predicate Device | |
|---|---|---|
| Quantra Hemostasis Analyzer | ||
| and QPlus Cartridge | ||
| (Subject of Special 510(k)) | Quantra Hemostasis Analyzer | |
| and QPlus Cartridge | ||
| (K230461) | ||
| Similarities | ||
| Manufacturer | Same as predicate | HemoSonics, LLC |
| Trade Name | Same as predicate | Quantra Hemostasis Analyzer |
| Common Name | Same as predicate | Whole Blood Hemostasis System |
| Classification Name | Same as predicate | Coagulation system for the measurement of |
| whole blood viscoelastic properties in | ||
| perioperative patients | ||
| Regulation Number | Same as predicate | 21 CFR 864.5430 |
| Product Code | Same as predicate | QFR |
| Device Class | Same as predicate | II |
| Location of Use | Same as predicate | Point of care and laboratory settings |
| Disposables | Same as predicate | QPlus Cartridge (multichannel cartridge) |
| Quantra Quality Controls (Level 1 and Level 2) | ||
| Analyzer Hardware | Same as predicate | Quantra Hemostasis Analyzer HS-002 |
| Indications for use | Same as predicate | The Quantra Hemostasis Analyzer is an |
| automated in vitro diagnostic device intended to | ||
| provide indications of the coagulation state of a | ||
| patient's whole blood sample. The Quantra uses | ||
| SEER Sonorheometry to measure the kinetic | ||
| changes as the sample clots in real time. The | ||
| Quantra output consists of numerical values for | ||
| clot time and clot stiffness-based coagulation | ||
| parameters. Quantra is for use by professionals at | ||
| the point of care or in a laboratory setting. |
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 |
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K232215 Quantra® Hemostasis Analyzer and QPlus Cartridge Special 510(k) Device Modification to K230461
| Modified Device | Predicate Device | |
|---|---|---|
| Quantra Hemostasis Analyzer | Quantra Hemostasis Analyzer | |
| and QPlus Cartridge | and QPlus Cartridge | |
| (Subject of Special 510(k)) | (K230461) | |
| characteristics via the intrinsic and extrinsic | ||
| pathways and includes tests with a heparin | ||
| neutralizer. | ||
| The QPlus 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 Time with | ||
| Heparinase (CTH), Clot Stiffness (CS), | ||
| Fibrinogen Contribution to Clot Stiffness (FCS), | ||
| Clot Time Ratio (CTR), and Platelet | ||
| Contribution to Clot Stiffness (PCS). | ||
| The QPlus Cartridge 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 QPlus Cartridge should | ||
| not be the sole basis for patient diagnosis. | ||
| For prescription use only. | ||
| Intended Use | Same as predicate | Same as Indications for Use |
| Sample Type(s) | Same as predicate | Arterial and venous whole blood |
| Microsoft Windows Operating System | Same as predicate | Windows 10 IoT Enterprise LTSC |
| Maximum assay time for QPlus Cartridge | ||
| for calculating CT, CTH, CTR results | Same as predicate | 15 minutes from test initiation |
| Differences | ||
| Analyzer Software | V2.4.1 | V2.2.16 |
| Maximum assay time for QPlus Cartridge | ||
| for calculating CS, PCS, FCS results | 25 minutes from test initiation | 15 minutes from test initiation |
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J. CLINICAL AND NON-CLINICAL STUDIES
The following studies were conducted to support this modification:
Interfering Substance Testing
The interference study tested substances for which "Not Computable" results due to delayed clot initiation were reported for CS and/or FCS in the studies conducted in support of DEN180017. For testing the modified device, similar protocols, acceptance criteria, and sample sizes were utilized. As only the direct-acting oral anticoagulants dabigatran and rivaroxaban generated results reported as "Not Computable" due to delayed clot initiation for CS and/or FCS, testing was limited to these two agents. As previously observed, rivaroxaban and dabigatran demonstrated a dose response effect of clot time parameter prolongation (starting at 100 ng/mL and at all levels tested, ≥ 25 ng/mL, respectively) and clot stiffness parameter reduction (starting at 200 and 100 ng/mL respectively).
Precision Testing: Whole Blood Repeatability Study
The precision study evaluated whole blood repeatability and assessed the precision of the modified device using whole blood samples across multiple instruments, operators, and cartridge lots. This whole blood repeatability study was performed with contrived whole blood requiring an assay time within the extended maximum assay time. Total imprecision, including variability between operators, cartridge lots, instruments, and test replicates ranged from 5.8% to 14.4% CV.
Clinical Performance Testing
Clinical samples were collected from adult cardiac surgery patients undergoing treatment in the intensive care unit at a single medical center. It was expected that this segment of the intended use population would enrich the sample set with samples expected to have delayed clot initiation.
Samples were analyzed on the modified Quantra System with the QPlus Cartridge in parallel with testing on the ROTEM delta (Werfen, Bedford, MA). Correlation analyses were performed to compare measurements obtained with the QPlus Cartridge to comparable measurements obtained with the ROTEM delta CT vs INTEM CT, CS vs EXTEM A20, FCS vs FIBTEM A20 and PCS vs PLATEM (defined as EXTEM A20 - FIBTEM A20).
Linear regression summary results for all comparisons showed r > 0.8 (0.82 to 0.94) for the correlation analysis, demonstrating a strong correlation of OPlus parameters to corresponding ROTEM delta parameters.
K. CONCLUSION
The submitted information in this premarket notification supports a substantial equivalence decision.