The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determinational Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.

Device Description

The Xprecia Prime™ Coagulation System has been specifically designed to monitor INR of patients undergoing anticoagulation therapy with warfarin (Vitamin K antagonist). It consists of the Xprecia Prime " Coagulation Analyzer, Xprecia Prime™ PT/INR Test Strips and Xprecia " Systems PT Controls.

The Xprecia Prime™ Coagulation System analyses a blood sample taken from the patient by fingerstick. The sample is transferred from the patient's finger to a test strip that has been inserted in the Xprecia Prime™ Coagulation Analyzer. The blood is mixed with a reagent contained within the strip and the analyzer detects when clotting has occurred. The result is then displayed on the analyzer's screen in either units known as the International Normalized Ratio (INR) or in calibrated seconds.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Xprecia Prime Coagulation System.

1. Table of Acceptance Criteria and the Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implicit/Explicit)	Reported Device Performance
Precision/Reproducibility
Intermediate Precision (CV)	$\le$5% (for 3 LOC's across the range)	Level 1: 2.2%
		Level 2: 1.0%
		Level 3: 1.1%
Reproducibility (CV)	$\le$6% (for LQC material)	Level 1: 2.0%
		Level 2: 1.3%
Capillary Repeatability (CV)	< 5% (overall across all sites and entire measuring range combined)	< 5%
Linearity/Assay Reportable Range	Assay reportable range verified via method comparison to reference device.	Established reportable range: 0.8 - 8.0 INR
Traceability	Traceable to WHO International Reference Preparation for thromboplastin.	Each lot factory calibrated to reference lot traceable to WHO International Reference Preparation.
Stability (Shelf Life)	Not explicitly stated, but 24 months was demonstrated.	24 months shelf life established.
Stability (In-Use)	Not explicitly stated, but 10 minutes at operating temperatures was demonstrated.	Can be kept outside vial for up to 10 minutes at all operating temperatures.
Stability (Transport)	Transport simulation requirements met.	Product appropriate for ambient shipping.
Detection Limit (Sensitivity)	Not explicitly stated in quantitative terms but sensitivity to specific factors was evaluated.	Sensitivity to Factor II: 50%, Factor V: 60%, Factor VII: 50%, Factor X: 60%.
Interference Limits	Specific limits for various interferents where results are unaffected at tested concentrations.	Refer to the detailed table in M.1.5 of the provided document.
Hematocrit Range	Not significantly affecting test results within 25-55% HCT.	Hematocrit range between 25-55% does not significantly affect test results.
Method Comparison (vs. Predicate Device CoaguChek®)	Correlation coefficient (r) or agreement statistics indicative of substantial equivalence (not explicitly stated numerically, but implied by the comparison results).	INR: Slope (0.939,0.985), Intercept (-0.083, 0.065), r = 0.97. PT seconds: Slope (0.940,0.985), Intercept (-0.998,0.736), r = 0.97.
Method Comparison (vs. Reference Device Sysmex® CS-2500)	Correlation coefficient (r) or agreement statistics indicative of strong correlation (not explicitly stated numerically).	INR: Slope (1.073,1.117), Intercept (-0.183, -0.056), r = 0.98. PT seconds: Slope (1.28,1.33), Intercept (-3.12, -1.56), r = 0.98.
Expected Values/Reference Range	A normal range of 0.9 to 1.1 INR with >95% of results falling within.	Normal range of 0.9 to 1.1 INR with more than 95% of all results falling within that range.

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

Precision/Reproducibility:
- Intermediate Precision: Single site, 20 days, two runs/day, two replicates (total N for LQC is not explicitly stated but implied by the study design).
- Reproducibility: 5-day study, multiple sites, untrained intended use operators (IUO), LQC material (total N for LQC not explicitly stated).
- Capillary Repeatability: Enrolled subjects, duplicate results (total N not given, but mentioned as "all sites").
Assay Reportable Range: Established through method comparison studies.
Interference Limits: Whole blood from normal subjects and patients on VKA therapy, spiked separately with interferents (N not explicitly stated).
Hematocrit Range: 371 patients across four intended use sites. Data collected included capillary blood samples for Xprecia Prime System INR, citrated plasma samples for central laboratory INR (Sysmex® CS-2500), and measured EDTA venous whole blood hematocrit.
Method Comparison with Predicate Device: 401 capillary samples. (Provenance: Not explicitly stated, but often multi-site clinical studies occur in the US for FDA submissions, however, the location specified for the predicate device comparison is not mentioned).
Method Comparison with Reference Device: 397 samples. Performed at 4 clinical sites in the US.
Expected Values/Reference Range: 120 patients who were not on oral anticoagulant therapy. (Provenance: Not explicitly stated, but likely from clinical sites involved in other studies).

Data Provenance: The studies for "Method Comparison with Reference Device" were performed at 4 clinical sites in the US. Most other studies imply fresh patient samples or LQC material, suggesting prospective data collection for the specific studies. The general provenance for all studies aside from the one specified as US is not explicitly stated in the provided text.

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

This device is an in-vitro diagnostic (IVD) device for measuring Prothrombin Time (PT) and International Normalized Ratio (INR), which are quantitative measurements. The ground truth for this type of device is typically established against a recognized reference method (e.g., laboratory analyzer) or a predicate device, rather than through expert consensus on qualitative interpretation.

For the method comparison studies:

Reference Method: Sysmex® CS 2500 laboratory analyzer using Dade® Innovin® reagent. This is an automated laboratory instrument, so it doesn't involve "experts" establishing ground truth in the traditional sense of medical image interpretation. The "ground truth" is the result provided by the established laboratory method.
Predicate Device: CoaguChek® XS System. Similarly, the predicate device's results serve as a comparative standard.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth for this specific IVD device is not directly applicable in the way it would be for, say, an AI-powered diagnostic imaging tool. The accuracy is assessed by comparing quantitative results to established analytical methods.

4. Adjudication Method for the Test Set:

Not applicable in the context of quantitative IVD assays compared to a reference method or predicate device. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to establish a qualitative ground truth (e.g., presence or absence of a disease in imaging). For this device, the "ground truth" is the numerical reading from the reference or predicate device/method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is an in-vitro diagnostic (IVD) system, a standalone quantitative measurement device for INR. It does not involve human readers interpreting images or data with or without AI assistance. Therefore, an MRMC study is not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies evaluate the standalone performance of the Xprecia Prime™ Coagulation System (meter and test strips). The system provides a direct INR or PT in seconds result. The "algorithm" or measurement principle of the device is evaluated directly against reference methods or predicate devices. There is no human interpretation step in the device's output itself; a healthcare professional uses the device to obtain a numerical result.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation (specifically for method comparison and reportable range) was:

Results from a reference laboratory analyzer: Siemens Sysmex® CS-2500 using Dade® Innovin® reagent.
Results from a predicate device: CoaguChek® XS System.
Expected values/reference range was established by testing samples from healthy individuals not on anticoagulant therapy.

8. The Sample Size for the Training Set:

The provided document describes performance studies, which generally fall under verification and validation (V&V) testing. For IVD devices, a "training set" is more relevant for machine learning algorithms. While the device contains software, the nature of the electrochemical measurement and factory calibration suggests a traditional development process. The document does not explicitly mention a "training set" in the context of developing a machine learning model. Instead, it refers to:

Factory calibration: "Each lot of Xprecia Prime™ PT/INR Test Strips is factory calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation." This calibration process uses reference materials to ensure accuracy, which is somewhat analogous to training but not typically quantified as a "sample size for a training set" in the ML sense.

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

As mentioned above, a "training set" in the machine learning sense is not explicitly detailed. The fundamental "ground truth" for the device's measurement integrity and accuracy is established through:

Traceability to WHO International Reference Preparation: For the PT/INR Test Strips, ensuring that the thromboplastin reagent is standardized against accepted international references.
Analytical methods and reference materials: The device's electrochemical detection method is designed to measure thrombin activity, correlated with accepted PT/INR values from established reference methods and predicate devices.

Summary

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March 15, 2024

Universal Biosensors Pty Ltd Nick Bliesner Head of Operations Universal Biosensors Pty Ltd 1 Corporate Avenue, Rowville, Victoria, 3178, Australia

Re: K230802

Trade/Device Name: Xprecia Prime Coagulation System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: March 15, 2023 Received: March 23, 2023

Dear Nick Bliesner:

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 When to Submit a 510(k) for a Software

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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 (OS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-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-S

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

Enclosure

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Indications for Use

510(k) Number (if known) K230802

Device Name Xprecia Prime™ Coagulation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Revision Number: 1.3.3

510K Summary Document

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A.	510(k) Summary
B.	Purpose for Submission
C.	Measurand
D.	Type of Test
E.	Applicant:
F.	Proprietary & Established Name:
G.	Regulatory Information:
G.1	Regulation section:
G.2	Classification:
G.3	Product code:
G.4	Panel:
H.	Intended Use:
I.	Device Description
J.	Substantial Equivalence Information Predicate device
K.	Standard/Guidance Document Referenced (if applicable)
L.	Test Principle:
M.	Performance Characteristics
M.1	Analytical Performance
M.2	Comparison Studies
M.3	Clinical Studies
M.4	Clinical Cut-Off
M.5	Expected Values/Reference range
N.	Instrument Name
0.	System Description
0.1	System Identification
0.2	Specimen Sampling and Handling
P.	Calibration
P.1	Xprecia Prime™ PT/INR Test Strips:
P.2	Xprecia Prime™ Coagulation Analyzer:
Q.	Software
R.	Cybersecurity
oi	Proposed Labeling
T.	Conclusion

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510 (K) Summary - Xprecia Prime™ Coagulation System

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A. 510(k) Summary

This Document is the 510 (K) summary for Xprecia Prime™ Coagulation System

B. Purpose for Submission

New Device

C. Measurand

Prothrombin time in INR (International Normalized Ratio) and seconds

D. Type of Test

Electrochemical technology with amperometric detection of thrombin activity

E. Applicant:

Sponsor	Universal Biosensors Pty Ltd1 Corporate Avenue, Rowville,Victoria, 3178,Australia
Correspondent	Primary 510(k) Contact:Nick BliesnerHead of OperationsUniversal Biosensors Pty Ltd1 Corporate Avenue, Rowville,Victoria, 3178,AustraliaPhone: +61 422475767e-mail: nbliesner@universalbiosensors.com

Alternate 510(k) Contact:

Dr Marcia L. Zucker Regulatory Consultant (USA Contact) Phone: 732-603-1194

E-mail: Mlzucker.zivd(@gmail.com

Proprietary & Established Name: F.

Proprietary /Trade Name: Xprecia Prime™ Coagulation System

Established /Common name: Prothrombin time test

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G. Regulatory Information:

Regulation section: G.1 21 CFR 864.7750, Prothrombin time test G.2 Classification: Class II G.3 Product code: GJS, Test, time, prothrombin Panel: G.4 Haematology (81) H. Intended Use:

The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determination of International Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.

Device Description I.

J. Substantial Equivalence Information

Predicate device

CoaguChek® XS System .

Predicate device 510(k) number

K060978 ●

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The Xprecia Prime™ Coagulation System is substantially equivalent to other products in
commercial distribution intended for similar use.

	New Device Xprecia	Predicate
Characteristics	Prime™ Coagulation System	CoaguChek® XS System
Intended Use/Indications for Use	The Xprecia Prime™ CoagulationSystem, which includes the INRCoagulation Analyzer (Meter) andPT/INR Test Strips, is for thedetermination of InternationalNormalized Ratio (INR) for themonitoring of oral anticoagulationtherapy with Warfarin (a vitamin Kantagonist) in fresh capillary wholeblood from a fingerstick. The resultsare reported in INR as well as inseconds. It is intended to be used tomonitor patients 18 years of age orolder who are stable on vitamin Kantagonist therapy for at least sixweeks and is not intended for use inpatients who are transitioning fromheparin treatment to vitamin Kantagonist therapy. The XpreciaPrime™ Coagulation System is anin-vitro diagnostic device intendedfor multi-patient use in professionalhealthcare settings including CLIAWaived and Point of care settings.	The CoaguChek® XS System isintended for use by professionalhealthcare providers forquantitative prothrombin timetesting for the monitoring ofwarfarin therapy. TheCoaguChek® XS System usesfresh capillary or non-anticoagulated venous wholeblood.
Measuring Range	0.8 to 8.0 INR	Same
Closed System	The Xprecia Prime™ CoagulationSystem, use Instrument and reagentstrips that are provided by UBI andare intended to be used together.	The CoaguChek® XS System, useInstrument and reagent strips thatare provided by Roche and areintended to be used together.
Specimen Type	Capillary whole blood	Capillary whole blood and non-anticoagulated venous wholeblood
Minimum Sample Volume	8 µL	10 µL
Operating Principle/Technology	Electrochemical technology withamperometric (electric current)detection of thrombin activity	Same
Characteristics	New DeviceXprecia PrimeTM Coagulation System	PredicateCoaguChek® XS System
Test Strip Reagent	Human recombinant thromboplastin	Same
Electronic On-board Quality Control	Bi-level on-board quality control checksto verify test strip integrity	Same
Strip Calibration	Each lot of test strips is calibrated to areference lot traceable to the WHOInternational Reference Preparation	Same
OperatingTemperature	15 °C to 32 °C (59 °F to 89 °F)	Same
Reference Range	INR: 0.9 to 1.1	Same
Test Strip Use Time	Within 10 minutes of removing from vial	Same
Hematocrit Range	Hematocrit range between 25 – 55 % donot significantly affect test results	Same
External LiquidQuality Control(LQC)	Liquid quality control in the normal andtherapeutic range (Optional)	No external liquid quality control
Test Strip Stability	24 months	21 months
Memory	640 patient results300 LQC results300 system messages	300 test results with date & time
Heparin	Warfarin patient test results are unaffectedby heparin concentrations up to 3 U/mL	Warfarin patient test results areunaffected by heparin concentrationsup to 0.8 U/mL
Low MolecularWeight Heparin	Test is insensitive to low molecularweight heparin (LMWH) up to 3 IU anti-factor Xa activity/mL	Insensitive to low molecular weightheparins up to 2 IU anti factor Xaactivity/mL.
Capillary Accuracy(All Sites)	Capillary blood on Xprecia PrimeTMCoagulation System vs. venous plasma ona Sysmex® CS 2500 laboratory analyzerusing Dade® Innovin®N=381y= 1.10 x -0.1Correlation: 0.97	Capillary blood on CoaguChek® XSvs. venous plasma on a SysmexAnalyzer using Dade Innovin (ISI =1.02)N=700y=1.006x + 0.032Correlation: 0.971

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K. Standard/Guidance Document Referenced (if applicable)

POCT 14 Point-of-care Coagulation Testing and Anticoagulation Monitoring, 2nd edition

CLSI GP41 - Collection of Diagnostic Venous Blood Specimens, 7th edition

CLSI EP05-A3 - Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.

CLSI EP09-c Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Third Edition.

CLSI EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Third Edition. CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline -Third Edition.

CLSI H47-A2 ne-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.

Test Principle: L.

M. Performance Characteristics

M.1 Analytical Performance

M.1.1 Precision/Reproducibility

Intermediate Precision verification study on the Xprecia Prime™ Coagulation System as per CLSI EP05-A3 guidelines.

As per CLSI EP05-A3 guidelines, Intermediate precision studies were conducted as a laboratory (single site) over 20 days, with two runs per days each consisting of two replicates. Testing carried out on the Xprecia Prime™ Coagulation System passed the acceptance criteria of CV ≤5% for the 3 LOC's (across the range).

LQC Level	Mean INR	Repeatability SD	Repeatability CV (%)
Level 1	1.18	0.03	2.2
Level 2	2.81	0.03	1.0
Level 3	6.52	0.07	1.1

Reproducibility: Intermediate Precision: (5-day Study) External multisite reproducibility study was conducted using the Xprecia Prime™ Coagulation System with LQC material to access the precision of the system in the hands of untrained intended use operators (IUO)over a period of 5 days. as per the acceptance criteria CV ≤6%.

LQC Level	Mean INR	Repeatability SD	Repeatability CV (%)
Level 1	1.19	0.02	2.0
Level 2	2.62	0.03	1.3

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Repeatability: Capillary repeatability for duplicate results from each enrolled subject demonstrated an overall CV < 5% across all sites and across the entire measuring range combined.

M.1.2 Linearity/assay reportable range:

A linearity study is not applicable to the Xprecia Prime™ Coagulation System

The assay reportable range (0.8 - 8.0 INR) of the Xprecia Prime™ Coagulation System was established through method comparison studies against the reference device (Sysmex® CS 2500 laboratory analyzer with Dade® Innovin® reagent).

M.1.3 Traceability, Stability, Expected values (control, calibrator, or methods)

M.1.3.1 Traceability

M.1.3.2 Xprecia Prime™ PT/INR Test Strips Stability

Real Stability: The stability of 24 months shelf life was established by storing three lots of Xprecia Prime™ PT/INR Test Strips at 5 +/- 3 ℃ (41 ºF) & 30 +/- 2 ℃ (86 ºF) and ambient to 75% Relative Humidity (RH) and testing using fresh whole blood and Liquid OC Samples.

In-Use Stability: In-use stability was tested to demonstrate that the Xprecia Prime™ PT/INR Test Strips can be kept outside the vial before measurement for up to 10 minutes at all operating temperatures.

Transport Stability: Xprecia Prime™ PT/INR Test Strips and packaging were validated by a transport stability study. The transport simulation requirements have been met and the product is appropriate for ambient shipping.

M.1.4 Detection Limit

The sensitivity to factors II, V, VII and X of the Xprecia Prime™ Coagulation System was performed by mixing varying amounts of factor II, V, VII and X deficient plasma, pooled normal plasma and red blood cells to final factor concentrations between 100% and 0%. These samples were then tested using nine Xprecia Prime TM Coagulation Analyzers and three Xprecia Prime™ PT/INR Test Strips lots in each factor sensitivity study. The sensitivity of the Xprecia Prime™ Coagulation System to factors II, V, VII and X was estimated as 50%, 60%, 50% and 60%, respectively.

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M.1.5 Analytical specificity Interference Limits:

Interference limits were established analyzing whole blood, obtained from normal subjects and patients on vitamin K antagonist (VKA) therapy, spiked separately with the interferents.

Interferent	Test Concentration
Acetaminophen	(Up to) 20 mg/L
Amoxicillin	(Up to)5.4 mg/dL
Apixaban	(Up to) 0.08 mg/L
Atorvastatin	(Up to) 96 mg/dL
Calcium Dobesilate	(Up to) 30 mg/L
Clexane	(Up to) 3 IU/mL
Cefitriaxone	(Up to) 84 mg/dL
Conjugated Bilirubin	(Up to) 40 mg/dL
Dabigatran	(Up to) 0.005 mg/L
Daptomycin	(Up to) 552 mg/L
Dexamethesone	(Up to) 12 mg/L
Edoxaban	(Up to) 0.06 mg/L
Ethinyl Estradiol	(Up to) 0.288 mg/L
Fondaparinux Sodium	(Up to) 5 mg/L
Hemoglobin	(Up to) 1000 mg/dL
Heparin	(Up to) 3300 U/L
Ibuprofen	(Up to) 219 mg/L
L-Ascorbic Acid	(Up to) 3 mg/dL
Lactate Dehydrogenase	(Up to) 250 U/L
Levonorgestrel	(Up to) 1.8 mg/L
Potassium Chloride	(Up to) 5 mmol/L
Prasugrel	(Up to) 72 mg/L
Prednisolone	(Up to) 3 mg/L
Protamine Sulfate	(Up to) 7.5 mg/L
Rivaroxaban	(Up to) 0.06 mg/L
Sodium Salicylate	(Up to) 0.0695 g/dL
Testosterone	(Up to) 480 mg/L
Ticagrelor	(Up to) 108 mg/L
Triglycerides	(Up to) 1500 mg/dL
Unconjugated Bilirubin	(Up to) 40 mg/dL
Uric Acid	(Up to) 24 mg/dL

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Note: Anti-phospholipid (APA) and Lupus Anticoagulant (LA)

Anti-phospholipid (APA) and Lupus Anticoagulant (LA) positive patients may observe falsely prolonged INR values that do not reflect the exact degree of anti-coagulation on the Xprecia Prime™ Coagulation System. Where APA/LA is suspected to be present a PT/INR result should be confirmed on a laboratory-based APA/LA insensitive method.

M.1.6 Hematocrit:

The hematocrit range was evaluated for the Xprecia Prime™ Coagulation Analyzer using capillary blood samples from 371 patients across four intended use sites. Capillary blood samples for INR determinations using the Xprecia Prime™ Coagulation System, citrated plasma samples for the central laboratory INR using the Siemens Sysmex® CS-2500, and the measured EDTA venous whole blood hematocrit for each test subject were used in the analysis. The %bias of the Xprecia Prime™ Coagulation System INR to the Sysmex® CS-2500 INR was calculated for each test subject and plotted against the hematocrit for that test subject. Data analysis demonstrated that hematocrit range between 25 - 55% does not significantly affect test results.

M.1.7 Assay cut-off

Not Applicable

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M.2 Comparison Studies

M.2.1 Method comparison with predicate Device CoaguChek®

Method Comparison Results for Xprecia Prime™ Coagulation System Vs Roche CoaguChek® -INR
Matrix	N	Xprecia Prime™ Range	CoaguChek®	Slope (95%CI)	Intercept (95%CI)	(r)
Capillary	401	0.8-7.6	0.9-7.9	0.96	-0.01	0.97
				(0.939,0.985)	(-0.083, 0.065)

Method Comparison Results for Xprecia Prime™ Coagulation System Vs Roche CoaguChek®-PT seconds
Matrix	N	Xprecia Prime™Range	CoaguChek®	Slope(95%CI)	Intercept(95%CI)	(r)
Capillary	401	9.7-91.6	10.5-96.0	0.962(0.940,0.985)	-0.131(-0.998,0.736)	0.97

Method Comparison with Reference device

A method comparison study was performed at 4 clinical sites in the US. The study showed:

N	XpreciaPrime™ Range	Sysmex® Range	Slope(95%CI)	Intercept(95%CI)	(r)
397	0.8-7.7	0.9-7.2	1.1(1.073,1.117)	-0.12(-0.183, -0.056)	0.98

Method Comparison Results for Xprecia Prime™ Coagulation System Vs Sysmex® CS-2500-PT seconds
N	XpreciaPrime™ Range	Sysmex® Range	Slope(95%CI)	Intercept(95%CI)	(r)
397	9.7-95.5	9.55-72.6	1.307(1.28,1.33)	-2.341(-3.12, -1.56)	0.98

M.3 Clinical Studies

M.3.1.1 Clinical Sensitivity Not applicable

M.3.1.2 Clinical Specificity Not applicable

M.3.1.3 Other Clinical supportive data

Not applicable

M.4 Clinical Cut-Off

Not applicable 510K Summary - 510(k) Xprecia Prime TM Coagulation System

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M.5 Expected Values/Reference range

Normal range testing was conducted on 120 patients who were not on oral anticoagulant therapy. Capillary samples were collected from each patient. Samples were tested on three lots of Xprecia Prime™ PT/INR Test Strips. Results demonstrated a normal range of 0.9 to 1.1 INR with more than 95% of all results falling within that range.

N. Instrument Name

Xprecia Prime™ Coagulation System

O. System Description

0.1 System Identification

The Xprecia Prime™ Coagulation System is a closed system, which is intended to be used exclusively with the Xprecia PrimeTM PT/INR Test Strips manufactured by Universal Biosensors.

O.2 Specimen Sampling and Handling

Whole blood is manually applied to the target area of the test strip from top as a hanging drop of blood from the fingerstick (Capillary).

P. Calibration

Xprecia Prime™ PT/INR Test Strips: P.1

Each lot of Xprecia Prime™ PT/INR Test Strips is factory calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation. An International Sensitivity Index (ISI) and Mean Normal Prothrombin Time (MNPT) values are assigned by calibration for each lot and embedded on the barcode label on the test strip vial along with the lot number and expiration date. Metrological traceability was achieved by following Annex 6 Guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists (replacement of WHO Technical Report Series 889 Annex 3)

P.2 Xprecia Prime™ Coagulation Analyzer:

When the analyzer is first turned on, the instrument performs a series of electronics, signal, software and memory integrity checks, as well as ensuring there is sufficient battery voltage to operate the Xprecia Prime™ Coagulation Analyzer. The key tests during this phase are the Heater/Thermistor check along with the Strip Port Hardware check. These are part of the overall Electronics Integrity Check. Failure to pass any of these power-on tests will prevent further operation of the analyzer.

Q. Software

The user interface of the Xprecia Prime™ Coagulation Analyzer guides the user through the test procedure step by step. The user only needs to insert the strip and apply a blood sample. The Xprecia Prime M Coagulation Analyzer measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay and displays the result as seconds and INR. After the test is completed, the meter automatically saves the test result.

R. Cybersecurity

Cybersecurity evaluation and risk management documentation was prepared according to FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

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Image /page/16/Picture/0 description: The image shows a logo and text on a blue background. The logo is on the left side of the image and consists of a gray, curved shape and a red drop. The text on the right side of the image reads "510 (K) Summary - Xprecia Prime™ Coagulation System". The text is white and in a sans-serif font.

(October 2, 2014) and ANSI UL 2900-2-1, Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems.

S. Proposed Labeling

The Labeling is prepared as per the requirements of 21 CFR Part 809.10, Labeling for in vitro diagnostic products.

T. Conclusion

The results of these studies demonstrate that the Xprecia Prime ™ Coagulation System is similar to the predicate in Intended Use. The data presented are a summary of external clinical evaluation, internal laboratory evaluation, and software development information. The Xprecia Prime™ Coagulation System's performance was shown to be substantially equivalent to the predicate device and demonstrated a strong correlation to the reference method.

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).