Quantra Hemostasis Analyzer

K232215 · Hemosonics, LLC · QFR · Aug 24, 2023 · Hematology

Device Facts

• Record ID: K232215
• Device Name: Quantra Hemostasis Analyzer
• Applicant: Hemosonics, LLC
• Product Code: QFR · Hematology
• Decision Date: Aug 24, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5430
• Device Class: Class 2

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, 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 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.

Device Story

Quantra Hemostasis Analyzer; point-of-care/laboratory diagnostic system; measures whole blood viscoelastic properties. Input: whole blood sample in QPlus Cartridge. Transformation: ultrasonic technology (Sonic Estimation of Elasticity via Resonance - SEER) measures clot stiffness; software processes resonance data. Output: clot stiffness results. Modification: software update extends maximum assay time for QPlus Cartridge from 15 to 25 minutes. Used by trained healthcare professionals; provides coagulation status data to inform clinical decision-making regarding hemostasis management in perioperative patients.

Clinical Evidence

Clinical performance testing compared modified Quantra System (QPlus) to ROTEM delta using samples from adult cardiac surgery patients. Correlation analysis (n=not specified) showed strong correlation (r > 0.8; range 0.82-0.94) between QPlus parameters (CT, CS, FCS, PCS) and ROTEM delta equivalents (INTEM CT, EXTEM A20, FIBTEM A20, PLATEM). Precision testing (whole blood repeatability) showed total imprecision CVs ranging from 5.8% to 14.4%.

Technological Characteristics

Viscoelastic coagulation analyzer; utilizes Sonic Estimation of Elasticity via Resonance (SEER) technology. Software-controlled assay timing. Modification extends QPlus Cartridge assay duration to 25 minutes. System is designed for point-of-care or laboratory use.

Indications for Use

Indicated for perioperative patients requiring in vitro measurement of whole blood viscoelastic properties to assess coagulation status. Intended for use by trained healthcare professionals in clinical or laboratory settings.

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

• Quantra QPlus System (K230461)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K232215

B Applicant

HemoSonics, LLC

C Proprietary and Established Names

Quantra Hemostasis Analyzer

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QFR | Class II | 21 CFR 864.5430 - Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties In Perioperative Patients | HE - Hematology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II, device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device (K230461).
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for implementing a software change on the Quantra Hemostasis Analyzer to extend the QPlus Cartridge maximum assay time for reporting clot stiffness results from 15 minutes to 25 minutes.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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