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 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, liver transplantation, and peripartum obstetric 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.

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 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).

AI/ML Overview

The FDA 510(k) clearance letter for the Quantra QStat Cartridge describes its intended use for evaluating blood coagulation and clot lysis, specifically extending its indication to peripartum obstetric patients. The submission refers to non-clinical and clinical tests to demonstrate the device meets acceptance criteria.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, it describes acceptable performance in relation to interference and clinical agreement.

Acceptance Criteria (Implied from Study Description)	Reported Device Performance
No significant interference from common obstetric medications (hemabate, methergine, misoprostol, oxytocin)	The highest concentration of each substance tested showed no significant interference in whole blood samples collected in 3.2% sodium citrate anticoagulant collection tubes.
Clinical agreement between QStat CSL and ROTEM delta EXTEM ML for identifying fibrinolytic samples.	Overall agreement of patient sample assignments into lysis-positive and lysis-negative based on data for QStat CSL and ROTEM delta EXTEM ML was 92%.
Correlation between QStat FCS and fibrinogen levels.	Passing-Bablok regression analysis showed good agreement between the methods (slope = 1, r = 0.815), albeit with a constant bias.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 322 subjects
Data Provenance: Prospective observational study, conducted across seven clinical sites in the US. The study involved parturients (women in labor) aged 18 years or older with concerns for coagulopathy.
Sample Size (Interference Study): Not explicitly stated with a specific number for the test set, but it mentioned "normal and hypercoagulable whole blood specimens" and that the "number of replicates at each level of a screening study was targeted to provide a 95% confidence interval (2-sided), per CLSI EP07-A2 Guideline."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test set. Instead, ground truth for some parameters appears to be established by comparison to other legally marketed and established devices (ROTEM delta, TEG 5000) and conventional coagulation testing (aPTT, PT/INR, fibrinogen level, platelet count).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts for establishing ground truth. The comparison is made against existing, accepted methods and devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. This device is an in vitro diagnostic (IVD) device that measures coagulation parameters, not an AI-assisted diagnostic imaging or interpretation tool.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies described are standalone performance studies. The clinical and analytical specificity studies evaluate the performance of the QStat Cartridge and Quantra Hemostasis Analyzer directly, not in conjunction with human interpretation for the primary measurement. The comparisons are to other standalone diagnostic methods (ROTEM delta, TEG 5000, conventional coagulation tests).

7. Type of Ground Truth Used

The ground truth used for the clinical performance evaluation was based on:

Comparison to legally marketed viscoelastic testing devices: ROTEM delta or TEG 5000.
Comparison to conventional coagulation testing: aPTT, PT/INR, fibrinogen level, platelet count.
The "concern for coagulopathy" as a trigger for testing suggests clinical suspicion as an initial selection criterion, with the aforementioned tests serving as the gold/reference standard for comparison.

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The studies described appear to be focused on performance validation.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, there is no information on how its ground truth was established.

Summary

FDA 510(k) Clearance Letter - Quantra QStat Cartridge

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 25, 2025

HemoSonics LLC
Garrett Sparks
Manager, Regulatory Affairs
4020 Stirrup Creek Drive
Suite 105
Durham, North Carolina 27703

Re: K251404
Trade/Device Name: Quantra 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: May 6, 2025
Received: July 24, 2025

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 (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.

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K251404 - Garrett Sparks
Page 2

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 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 QS 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 (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-safety-reporting-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251404 - Garrett Sparks
Page 3

assistance/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,

Takeesha Taylor-bell -S

Takeesha Taylor-Bell
Deputy Director
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

Page 4

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251404

Device Name: QStat Cartridge

Indications for Use (Describe)

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."

Page 5

510(K) SUMMARY

APPLICANT INFORMATION

Date prepared: 21 August 2025
Submission Date: May 2025

Submitter Information: HemoSonics, LLC
4020 Stirrup Creek Drive, Suite 105
Durham, NC 27703
Phone: 919-599-7325

Contact Person: Garrett Sparks
Email: gsparks@hemosonics.com
Phone: 919-599-7325

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 extend the intended use and indications for use statement for the QStat Cartridge to peripartum obstetric patients. 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, clot lysis, 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).

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INTENDED USE AND INDICATIONS FOR USE STATEMENT

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

For prescription use only.

DEVICE DESCRIPTION

Page 7

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).

Table 1. QStat Cartridge Output Parameters

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

Channels	Reagents	Parameter
2&3	See above	Clot Stability to Lysis (CSL) (percent)
3&4	See above	Platelet Contribution to Clot Stiffness (PCS) (hectoPascals)

DEVICE MODIFICATION DESCRIPTION

The QStat Cartridge was initially cleared under K213917 for liver transplantation and trauma patients. An additional submission (K240045) added a sample matrix claim of arterial whole blood. This 510(k) adds the peripartum obstetric patient as an additional patient population.

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TECHNOLOGICAL COMPARISON

The software version used for this submission version is 2.4.1. This is the same version used for previous submission K240045. This version does not change any output from the Quantra Instrument or QStat Cartridge cleared in DEN180017 or K213917.

SUBSTANTIAL EQUIVALENCE INFORMATION

Predicate Device Name: QStat Cartridge
Predicate 510(k) Number: K240045

Comparison with the Predicate:

Table 2 provides an overall comparison of the modified QStat Cartridge with the previously cleared QStat Cartridge.

Table 2: Comparison between K240045 and Modified QStat Cartridge

	Modified Device	Predicate Device
	Quantra System (Subject of 510(k))	Quantra QStat System (K240045)
Similarities
Manufacturer	HemoSonics, LLC	Same
Trade Name	Quantra 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
Reagents	Channel 1: Kaolin, CalciumChannel 2: Thromboplastin, Calcium, Polybrene, Tranexamic AcidChannel 3: Thromboplastin, Calcium, PolybreneChannel 4: Thromboplastin, Calcium, Polybrene, Abciximab	Same
Test Results	CT, CS, PCS, FCS, CSL	Same

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	Modified Device	Predicate Device
	Quantra System (Subject of 510(k))	Quantra QStat System (K240045)
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 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, liver transplantation, and peripartum obstetric procedures.Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.For prescription use only.	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 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.
Analyzer Software	Ver 2.4.1	Same

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NON-CLINICAL AND CLINICAL TESTS SUMMARY AND CONCLUSIONS

An analytical specificity study was conducted to evaluate potential sources of exogenous interference in the obstetric patient population for the QStat Cartridge on the Quantra.

The Interference Study included screening studies evaluating the following potential interferents: hemabate (carboprost tromethamine), methergine (methylergonovine maleate), misoprostol, and oxytocin (Pitocin). The study involved testing each potential interferent with normal and hypercoagulable whole blood specimens as a screening study. In screening studies, potential sources of interference were tested both at one (1) level of interferent ("Test") and without interferent ("Control"). The number of replicates at each level of a screening study was targeted to provide a 95% confidence interval (2-sided), per CLSI EP07-A2 Guideline.

The clinical performance of the Quantra Hemostasis Analyzer with the QStat Cartridge was evaluated in a multi-center prospective observational study involving parturients 18 years or older undergoing labored or non-labored delivery for which there was a concern for coagulopathy. Three hundred twenty-two subjects were eligible for this study across seven clinical sites in the US. Results from the QStat Cartridge were compared to equivalent results from the ROTEM delta or TEG 5000 as well as conventional coagulation testing (aPTT, PT/INR, fibrinogen level, platelet count). Testing was performed upon ordering standard of care coagulation testing or viscoelastic testing for suspected coagulopathy and, in some cases, at the time of hemorrhage or after hemorrhage when blood products or other interventions were delivered for up to 4 samples per patient.

Correlation and clinical agreement analyses were performed to compare measurements obtained with the QStat Cartridge to comparable measures obtained with the ROTEM delta or TEG 5000.

For the analytical specificity study, the highest concentration of each substance tested showed no significant interference in whole blood samples collected in 3.2% sodium citrate anticoagulant collection tubes.

For the method comparison study, a clinical agreement analysis was performed to evaluate the ability of the QStat CSL parameter to identify fibrinolytic samples relative to the ROTEM delta lysis parameter EXTEM ML. The overall agreement of patient sample assignments into lysis-positive and lysis-negative based on data for QStat CSL and ROTEM delta EXTEM ML was 92%.

The correlation between QStat FCS and fibrinogen levels was assessed using Passing-Bablok regression analysis. Results showed good agreement between the methods (slope =1, r=0.815) albeit with a constant bias.

Regulation Number and Section

§ 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.