(82 days)
Not Found
No
The document describes a device that uses proprietary technology (SEER Sonorheometry) to measure viscoelastic properties of blood. There is no mention of AI or ML in the intended use, device description, or the specific sections dedicated to identifying AI/ML components.
No.
The device is for in vitro diagnostic use, intended to evaluate blood coagulation and clot lysis in patients, not to provide therapy.
Yes
This device is explicitly stated to be for "in vitro diagnostic use" and is intended to "evaluate the viscoelastic properties of whole blood" to assess "possible hypocoagulable and hypercoagulable conditions," which are diagnostic purposes.
No
The device description clearly states that the QStat Cartridge is a "single-use, multi-channel disposable plastic cartridge" and is a physical component used with the Quantra Hemostasis Analyzer. It is pre-filled with reagents and is in direct contact with the blood sample. This indicates it is a hardware component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The OStat Cartridge is intended for in vitro diagnostic use by trained professionals at the point-of-care and in clinical laboratories..."
- Sample Type: It analyzes a "3.2% citrated venous or arterial whole blood sample." This is a biological sample taken from the human body.
- Purpose: It provides "semi-quantitative indications of the coagulation and clot lysis state" and evaluates "the viscoelastic properties of whole blood" to "assess possible hypocoagulable and hypercoagulable conditions." This is diagnostic information about a patient's health status.
- Device Description: It describes how the cartridge interacts with the blood sample and uses reagents to perform tests.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of a patient with a potential recipient, or to monitor therapeutic measures.
No.
The clearance letter explicitly states "Predetermined Change Control Plan (PCCP) - All Relevant Information: Not Found". This indicates that the device is not authorized as a PCCP authorized device.
Intended Use / Indications for Use
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coaqulation 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 OStat 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 and liver transplantation procedures.
Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.
For prescription use only.
Product codes
QFR
Device Description
The QStat Cartridge is a single-use, multi-channel disposable plastic cartridge used with the Quantra Hemostasis Analyzer for the evaluation of blood coagulation and clot lysis. The measurements are performed in four test channels of the disposable cartridge which enable differential testing 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. The QStat Cartridge is intended for use in patients 18 years or older by professionals in a hospital setting (point of care or laboratory) to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures.
Each QStat Cartridge is pre-filled with lyophilized reagent beads individually sealed in an airtight pouch. After a QStat Cartridge is removed from its primary packaging, it is inserted into the instrument dock. A whole blood sample, collected in a 3.2% sodium citrate anticoagulant blood collection tube (minimum volume 2.7 mL), is attached directly to the cartridge and the test is initiated using the touch screen interface on the Quantra Hemostasis Analyzer. The cartridge is the only component of the Quantra System that is in direct contact with blood. The fluidic system within the instrument draws the sample into the cartridge where it is warmed to 37°C, aliquoted, introduced and mixed with the lyophilized reagents, and analyzed. When the test is complete, the cartridge is released from the dock to be disposed of in an appropriate biosafety sharps container.
Table 1 summarizes the lyophilized reagents contained in each cartridge channel of the QStat Cartridge and the output parameter reported. Clot times and clot stiffness values obtained from the measurements performed by the QStat 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 assay provides the following information for each patient sample: Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Stability to Lysis (CSL).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 27, 2024
HemoSonics LLC Deborah Winegar Vice-President, Clinical Affairs 4020 Stirrup Creek Drive Suite 105 Durham, North Carolina 27703
Re: K240045
Trade/Device Name: QStat Cartridge 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: QFR Dated: March 19, 2024 Received: March 19, 2024
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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding
1
When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Min Wu
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
| Submission Number (if known) |
|---|
Device Name
QStat Cartridge
Indications for Use (Describe)
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coaqulation 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 OStat 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 and liver transplantation procedures.
Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.
For prescription use only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SPECIAL 510(K) SUMMARY
APPLICANT INFORMATION
| Submission Date: | January 2024 |
|---|---|
| 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 |
PROPRIETARY AND ESTABLISHED NAMES
QStat® Cartridge
REGULATORY INFORMATION
| Trade/Device Name: | QStat Cartridge |
|---|---|
| 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 |
PURPOSE OF SUBMISSION
To add a sample matrix to the intended use and indications for use statement for the QStat Cartridge. This change does not alter the device's fundamental scientific technology.
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.
TYPE OF TEST
The QStat Cartridge is an in vitro diagnostic device used with the Quantra Hemostasis Analyzer to assess a patient's coagulation system by measuring the viscoelastic properties of a blood sample during clot formation and clot lysis. The QStat Cartridge is used with the Quantra Hemostasis Analyzer (instrument) and QStat Controls (external Quality Control materials).
4
INTENDED USE AND INDICATIONS FOR USE STATEMENT
The OStat 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 OStat Cartridge is intended for in vitro diagnostic use by trained professionals at the pointof-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 OStat 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 and liver transplantation procedures.
Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.
For prescription use only.
DEVICE DESCRIPTION
The QStat Cartridge is a single-use, multi-channel disposable plastic cartridge used with the Quantra Hemostasis Analyzer for the evaluation of blood coagulation and clot lysis. The measurements are performed in four test channels of the disposable cartridge which enable differential testing 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. The QStat Cartridge is intended for use in patients 18 years or older by professionals in a hospital setting (point of care or laboratory) to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures.
Each QStat Cartridge is pre-filled with lyophilized reagent beads individually sealed in an airtight pouch. After a QStat Cartridge is removed from its primary packaging, it is inserted into the instrument dock. A whole blood sample, collected in a 3.2% sodium citrate anticoagulant blood collection tube (minimum volume 2.7 mL), is attached directly to the cartridge and the test is initiated using the touch screen interface on the Quantra Hemostasis Analyzer. The cartridge is the only component of the Quantra System that is in direct contact with blood. The fluidic system within the instrument draws the sample into the cartridge where it is warmed to 37°C, aliquoted, introduced and mixed with the lyophilized reagents, and analyzed. When the test is complete, the cartridge is released from the dock to be disposed of in an appropriate biosafety sharps container.
5
Table 1 summarizes the lyophilized reagents contained in each cartridge channel of the QStat Cartridge and the output parameter reported. Clot times and clot stiffness values obtained from the measurements performed by the QStat 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 assay provides the following information for each patient sample: Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Stability to Lysis (CSL).
| Channel | Reagents | QStat Cartridge Output Parameter (units of measure) |
|---|---|---|
| 1 | Kaolin, calcium buffers | |
| &stabilizers | Clot Time (CT) (seconds) | |
| 2 | Thromboplastin, tranexamic acid | |
| (TXA), polybrene, calcium, | ||
| buffers, and stabilizers | No direct output (see calculated parameters) | |
| 3 | Thromboplastin, polybrene, | |
| calcium, buffers & stabilizers | Clot Stiffness (CS) (hectoPascals) | |
| 4 | Thromboplastin, polybrene, | |
| abciximab, calcium, buffers & | ||
| stabilizers | Fibrinogen Contribution (FCS) (hectoPascals) | |
| Calculated Parameters | ||
| 2&3 | See above | Clot Stability to Lysis (CSL) (percent) |
| 3&4 | See above | Platelet Contribution to Clot Stiffness (PCS) (hectoPascals) |
Table 1. QStat Cartridge Output Parameters
The analyzer displays the test results (n=5) in three different views: dial display screen, stiffness curves data, and trend screen. The dial display screen is the primary viewing screen and has a dial for each of the five output parameters. Each dial shows the reference range, assay measurement range, parameter abbreviation, and the numerical result for the corresponding parameter. The stiffness curves are a graphical display of shear modulus measurements over time that enable the user to view the development of clot stiffness over time. The trends screen displays results from a patient for up to six time points.
There are two levels of external OStat Controls (QSL1 and OSL2) that are supplied separately (required but not provided materials) for testing on the Quantra System when changing cartridge lots, changing control lots, or after significant changes are made to the Quantra instrument (e.g., software update).
DEVICE MODIFICATION DESCRIPTION
The QStat Cartridge was previously cleared under K213917 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 QStat Cartridge in order to expand the sample matrices accepted on this system.
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SUBSTANTIAL EQUIVALENCE INFORMATION
Predicate Device Name: QStat Cartridge
Predicate 510(k) Number: K213917
Comparison with the Predicate:
Table 2 provides an overall comparison of the modified QStat Cartridge with the previously cleared QStat Cartridge.
| Modified Device | Predicate Device | |
|---|---|---|
| QStat Cartridge | ||
| (Subject of Special 510(k)) | QStat Cartridge | |
| (K213917) | ||
| Similarities | ||
| Manufacturer | HemoSonics, LLC | Same |
| Trade Name | QStat Cartridge | 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 | QStat Cartridge (multichannel cartridge) | |
| Quantra Quality Controls (Level 1 and Level 2) | Same | |
| Analyzer Hardware | Quantra Hemostasis Analyzer HS-002 | Same |
| Differences | ||
| 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 | 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 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 |
| | Modified Device | Predicate Device |
| | QStat Cartridge | QStat Cartridge |
| | (Subject of Special 510(k)) | (K213917) |
| | Stiffness (CS), Fibrinogen Contribution to
Clot Stiffness (FCS), Platelet Contribution
to Clot Stiffness (PCS), and Clot Stability
to Lysis (CSL). | 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 and
liver transplantation procedures. | 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 and
liver transplantation procedures. |
| | Results obtained with the QStat Cartridge
should not be the sole basis for patient
diagnosis. | Results obtained with the QStat Cartridge
should not be the sole basis for patient
diagnosis. |
| | For prescription use only. | For prescription use only. |
| Sample Type(s) | Arterial and venous whole blood | Venous whole blood |
| Analyzer Software | Ver 2.4.1 (cleared in K232215) | Ver 2.0.36 |
Table 2: Comparison between K213917 and Modified QStat Cartridge
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