QStat Cartridge

K213917 · Hemosonics, LLC · QFR · Nov 29, 2022 · Hematology

Device Facts

• Record ID: K213917
• Device Name: QStat Cartridge
• Applicant: Hemosonics, LLC
• Product Code: QFR · Hematology
• Decision Date: Nov 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5430
• Device Class: Class 2

Intended 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 whole blood sample using the Quantra® Hemostasis Analyzer. The QStat Cartridge includes tests to assess coagulation via the intrinsic 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 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 conditions in trauma and liver transplantation procedures. Results obtained with the OStat Cartridge should not be the sole basis for patient diagnosis. For prescription use only.

Device Story

Single-use, multi-channel plastic cartridge for Quantra Hemostasis Analyzer; assesses coagulation and clot lysis in hospital settings (POC/lab). Input: 3.2% citrated venous whole blood. Operation: Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry; ultrasound pulses generate shear waves to measure shear modulus (stiffness) during coagulation. Cartridge contains lyophilized reagents (kaolin, thromboplastin, polybrene, abciximab, tranexamic acid) in four channels. Output: Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL). Results displayed on analyzer screen as dials, stiffness curves, and trends. Assists clinicians in managing coagulation status during surgery/trauma; helps identify fibrinolysis and hypocoagulable states.

Clinical Evidence

Multi-center prospective observational study (n=125 liver transplant, n=159 trauma, n=5 normal). Compared QStat to ROTEM delta. Linear regression showed strong correlation (Pearson r=0.80-0.95). Clinical agreement for lysis detection (CSL vs EXTEM ML) was 92.6% overall. Additional comparison with TEG 6S (n=52) showed 91.7% agreement for lysis. Reader study (n=10) confirmed >95% correct interpretation of results.

Technological Characteristics

Single-use, 4-channel plastic cartridge. Sensing principle: SEER Sonorheometry (ultrasonic pulses). Reagents: Lyophilized beads (kaolin, thromboplastin, tranexamic acid, polybrene, abciximab, calcium). Dimensions: Disposable cartridge for Quantra Hemostasis Analyzer. Connectivity: Networked/standalone analyzer with touchscreen interface. Sterilization: Not specified. Software: Embedded firmware for signal processing and parameter calculation.

Indications for Use

Indicated for patients age 18+ undergoing trauma or liver transplantation procedures to assess hypocoagulable conditions. Used for in vitro diagnostic evaluation of blood coagulation and clot lysis.

Regulatory Classification

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.

Special Controls

The special controls for this device are:

*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.

Predicate Devices

• ROTEM delta Thromboelastometry System (K083842)
• EXTEM Assay, FIBTEM Assay, APTEM Assay for the ROTEM delta Thromboelastometry System (K101533)

Submission Summary (Full Text)

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November 29, 2022

HemoSonics, LLC Garrett Sparks Regulatory Affairs 400 Preston Avenue, Suite 250 Charlottesville, Virginia 22903

Re: K213917

Trade/Device Name: OStat® 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: OFR Dated: December 15, 2021 Received: December 15, 2021

Dear Garrett Sparks :

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.

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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 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 lectronic 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Min W

Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) 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 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 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 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 conditions in trauma and liver transplantation procedures.

Results obtained with the OStat Cartridge should not be the sole basis for patient diagnosis.

For prescription use only.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Hemosonics QStat Cartridge. The logo features a red blood drop with sound waves emanating from it on the left. To the right of the blood drop is the word "HEMOSONICS" in black, and below that is "QStat® Cartridge".

#### SECTION 5: 510(K) SUMMARY

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Image /page/4/Picture/1 description: The image shows the logo for Hemosonics QStat Cartridge. The logo features a stylized red blood drop with sound waves emanating from it. Next to the blood drop is the text "HEMOSONICS" in a sans-serif font. Below that is the text "QStat® Cartridge".

# 510(k) SUMMARY

## A. 510(k) NUMBER:

K213917

# B. PURPOSE OF SUBMISSION

Clearance of a new assay

#### C. MEASURAND

Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL)

#### D. TYPE OF TEST

Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry to measure the shear modulus of whole blood during coagulation and clot lysis, semi-quantitative

#### E. APPLICANT

HemoSonics, LLC

#### F. PROPRIETARY AND ESTABLISHED NAMES

QStat® Cartridge

#### G. REGULATORY INFORMATION

- 1. Regulation Section: 21 CFR 864.5430 - Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
- 2. Classification: Class II

#### 3. Product Code: QFR - Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

- 4. Panel: Hematology (81)

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Image /page/5/Picture/0 description: The image shows the logo for Hemosonics. The logo features a red blood drop with sound waves emanating from it. Below the logo is the text "QStat® Cartridge".

## H. INTENDED USE

- l. Intended use(s):
See Indications for use below

- 2. 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 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 OStat Cartridge should not be the sole basis for patient diagnosis.

For prescription use only.

- 3. Special conditions for use statement(s):
For prescription use only.

- 4. Special instrument requirements:
Quantra Hemostasis Analyzer

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Image /page/6/Picture/0 description: The image shows the logo for Hemosonics QStat Cartridge. The logo features a red blood drop with sound waves emanating from it, followed by the text "HEMOSONICS" in black. Below that is the text "QStat® Cartridge" in a smaller font, also in black.

#### DEVICE DESCRIPTION I.

The QStat Cartridge is a single-use, multi-channel (n=4) disposable plastic cartridge used with the Quantra Hemostasis Analyzer to assess a patient's coagulation and clot lysis (possible hypocoagulable and hypercoagulable conditions) in a hospital setting (point of care or laboratory) during trauma and liver transplantation procedures. The QStat Cartridge consists of four independent channels that can be tested simultaneously with Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry.

Each QStat Cartridge is pre-filled with reagents individually sealed in an airtight pouch. After a QStat Cartridge is removed from its primary packaging, it is inserted into the instrument dock. A venous 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℃, 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.

Each channel of the cartridge contains prefilled lyophilized reagents in the form of beads that enable differential testing without the need for any reagent preparation or pipetting before testing. 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). The following table summarizes the lyophilized reagents contained in the QStat Cartridge and the test function for each cartridge channel and the output parameter.

| Channel | Reagents | QStat Cartridge Output Parameter<br>(units of measure) |
|-----------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Measured Parameters | | |
| 1 | Kaolin, calcium, buffers and stabilizers | Clot Time (CT)<br>(seconds) |
| 2 | Thromboplastin, tranexamic acid (TXA),<br>polybrene, calcium, buffers, and stabilizers | No direct output (see calculated parameters) |
| 3 | Thromboplastin, polybrene, calcium, buffers,<br>and stabilizers | Clot Stiffness (CS)<br>(hectoPascals) |
| 4 | Thromboplastin, polybrene, abciximab,<br>calcium, buffers, and stabilizers | Fibrinogen Contribution to Clot Stiffness<br>(FCS) (hectoPascals) |
| Calculated Parameters | | |
| 2 & 3 | See above | Clot Stability to Lysis (CSL) (percent) |
| 3 & 4 | See above | Platelet Contribution to Clot Stiffness (PCS)<br>(hectoPascals) |

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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 six 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 QStat Controls (QSL1 and QSL2) 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).

The Quantra Cleaning Cartridge is an accessory for the Quantra Hemostasis Analyzer and is intended to be used for simple, periodic cleaning.

# J. SUBSTANTIAL EQUIVALENCE INFORMATION

- 1. Predicated Device Name:
ROTEM Delta Thromboelastometry System

- 2. Predicate 510(k) Numbers:
K083842 and K101533

- 3. Comparison with Predicate:

| | QStat Cartridge<br>(Proposed Device) | ROTEM Delta Thromboelastometry System<br>K083842 and K101533<br>(Predicates) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QStat Cartridge is a multi-channel<br>cartridge that provides semi-<br>quantitative indications of the<br>coagulation and clot lysis state of a<br>3.2% citrated venous whole blood<br>sample using the Quantra Hemostasis<br>Analyzer. The QStat Cartridge includes<br>tests to assess coagulation via the<br>intrinsic and extrinsic pathways and<br>includes a test with tranexamic acid to<br>evaluate clot lysis characteristics.<br>The QStat Cartridge is intended for in<br>vitro diagnostic use by trained<br>professionals at the point-of-care and in<br>clinical laboratories to evaluate the<br>viscoelastic properties of whole blood<br>by means of the following functional | K083842<br>The ROTEM® delta Thromboelastometry System is<br>designed for in vitro diagnostic use by professionals<br>in a laboratory environment. The ROTEM® delta is<br>intended to provide a qualitative and quantitative<br>indication of the coagulation state of a blood sample.<br>For this purpose, the ROTEM® delta records the<br>clot firmness changes in a sample of citrated whole<br>blood as the sample clots, retracts and lyses in real<br>time. The analyzer output consists of a qualitative<br>graphical representation (mirrored coagulation curve<br>- clot firmness over time) and several defined<br>numerical parameters describing the curve<br>quantitatively.<br>The in-TEM® assay is a semi-quantitative in vitro<br>diagnostic assay used to monitor the coagulation<br>process via the intrinsic pathway in citrated whole |
| QStat Cartridge<br>(Proposed Device) | ROTEM Delta Thromboelastometry System<br>K083842 and K101533<br>(Predicates) | |
| parameters: Clot Time (CT), Clot<br>Stiffness (CS), Fibrinogen Contribution<br>to Clot Stiffness (FCS), Platelet<br>Contribution to Clot Stiffness (PCS),<br>and Clot Stability to Lysis (CSL).<br><br>The QStat Cartridge is indicated for the<br>evaluation of blood coagulation and clot<br>lysis in patients age 18 years and older<br>to assess possible hypocoagulable and<br>hypercoagulable conditions in trauma<br>and liver transplantation procedures.<br><br>Results obtained with the QStat<br>Cartridge should not be the sole basis<br>for patient diagnosis.<br><br>For prescription use only. | blood specimens. Clotting characteristics are<br>described by the functional parameters Clotting<br>Time (CT), Speed of Clot formation (CFT and alpha<br>angle), Clot Firmness (A20/MCF) and Clot Lysis<br>(LOT, ML, LI(x)). The assay is intended for<br>professional use in the clinical laboratory on<br>the ROTEM® delta Instrument.<br><br>The hep-TEM® assay is a semi-quantitative in vitro<br>diagnostic assay used to monitor the coagulation<br>process via the intrinsic pathway in the presence of<br>heparin, in citrated whole blood specimens. Clotting<br>characteristics are described by the<br>functional parameters Clotting Time (CT), Speed of<br>Clot formation (CFT and alpha angle),<br>Clot Firmness (A20/MCF) and Clot Lysis (LOT,<br>ML, LI(x)). The assay is intended for professional<br>use in the clinical laboratory on the ROTEM® delta<br>Instrument.<br><br>The NATEM® assay is a semi-quantitative in vitro<br>diagnostic assay used to monitor the coagulation<br>process contact activated by the surface of the<br>measurement cell, in citrated whole blood<br>specimens. Clotting characteristics are described by<br>the functional parameters Clotting Time (CT), Speed<br>of Clot formation (CFT and alpha angle),<br>Clot Firmness (A20/MCF) and Clot Lysis (LOT,<br>ML, LI(x)). The assay is intended for professional<br>use in the clinical laboratory on the ROTEM® delta<br>Instrument.<br><br>The star-TEM® reagent is intended for use as<br>recalcification reagent in the NATEM and in-TEM<br>on the ROTEM® delta Thromboelastometry<br>System.<br><br>K101533<br>The EXTEM® assay is a semi-quantitative in vitro<br>diagnostic assay used to monitor the coagulation<br>process via the extrinsic pathway in citrated whole<br>blood specimens on the ROTEM® delta<br>Thromboelastometry System. Clotting<br>characteristics are described by the functional<br>parameters Clotting Time (CT), Speed of Clot<br>formation (CFT and alpha angle), Clot Firmness<br> | |
| | QStat Cartridge<br>(Proposed Device) | ROTEM Delta Thromboelastometry System<br>K083842 and K101533<br>(Predicates) |
| | | Thromboelastometry System to monitor the clot<br>firmness of a citrated whole blood specimen after<br>blocking platelet contribution to the clot firmness.<br>The fibTEM® is always used in conjunction with<br>exTEM®. Clotting characteristics are described by<br>the functional parameter Clot Firmness (A20/MCF).<br>The APTEM® assay is a semi-quantitative in vitro<br>diagnostic assay on the ROTEM® delta<br>Thromboelastometry System to monitor the clot<br>firmness of a citrated whole blood specimen after<br>blocking hyperfibrinolysis by aprotinin. The ap-<br>TEM® is always used in conjunction with ex-<br>TEM®. Clotting characteristics are described by<br>the functional parameters Clotting Time (CT), Speed<br>of Clot formation (CFT and alpha angle), Clot<br>Firmness (A20/MCF) and Clot Lysis (LOT, ML,<br>LI(x)). CFT and alpha (Speed of Clot Formation) are<br>complementary parameters and should be used<br>in conjunction with the main parameters Clotting<br>Time (CT) and Clot Firmness (A20/MCF). |
| | Similarities | |
| Classification | II | Same |
| Indications for<br>Use | Trauma and liver transplantation | Trauma, organ transplantation, cardiovascular<br>surgery, and cardiology procedures |
| Technological<br>Purpose | Measuring "clot stiffness" during clot<br>formation | Measuring "clot firmness" during clot formation |
| Measuring<br>Channels | 4 | Same |
| Sample Type | 3.2% sodium citrated whole blood | Same |
| Results Display | Graphical (curves) and numerical<br>display of patient results | Same |
| Measurands | Clot time (CT) | Same |
| Measurands | Clot Stiffness (CS) | Same. Reported as EXTEM A20 (clot firmness) |
| Measurands | Fibrinogen Contribution to Clot<br>Stiffness (FCS) | Same Reported as FIBTEM A20 |
| Reagents | Thromboplastin (extrinsic pathway) | Same…