Xprecia Prime Coagulation System
Device Facts
| Record ID | K230802 |
|---|---|
| Device Name | Xprecia Prime Coagulation System |
| Applicant | Universal Biosensors Pty, Ltd. |
| Product Code | GJS · Hematology |
| Decision Date | Mar 15, 2024 |
| Decision | SESE |
| Submission Type | Dual Track |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
Intended Use
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 Story
Xprecia Prime Coagulation System monitors INR in patients on Warfarin therapy. System consists of handheld analyzer and disposable PT/INR test strips. Operator performs fingerstick; applies capillary blood sample to test strip inserted in analyzer. Device uses electrochemical technology with amperometric detection of thrombin activity to measure clotting time. Analyzer displays results in INR and seconds. Used in professional healthcare settings (CLIA Waived/Point-of-care) by clinicians. Provides rapid, point-of-care monitoring to assist in managing anticoagulation therapy; benefits patients by enabling immediate clinical decision-making regarding Warfarin dosage.
Clinical Evidence
Clinical method comparison study conducted at 4 US sites (N=401) comparing Xprecia Prime to CoaguChek® XS (r=0.97) and to laboratory reference Sysmex® CS-2500 (N=397, r=0.98). Precision studies (CLSI EP05-A3) showed CV ≤5% for repeatability and ≤6% for reproducibility. Hematocrit range 25-55% does not significantly affect results. Interference testing performed for various drugs and endogenous substances.
Technological Characteristics
Electrochemical/amperometric sensing of thrombin activity. Uses human recombinant thromboplastin reagent. Handheld analyzer form factor. Operates 15°C to 32°C. Closed system; test strips factory-calibrated to WHO International Reference Preparation. Connectivity includes data storage (640 patient results, 300 LQC).
Indications for Use
Indicated for monitoring oral anticoagulation therapy with Warfarin in patients 18+ years old who are stable on therapy for at least six weeks. Not for patients transitioning from heparin. Used in professional healthcare settings including CLIA-waived and point-of-care environments.
Regulatory Classification
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).
Predicate Devices
- Coaguchek XS System (K060978)
Reference Devices
- Xprecia Systems PT Controls (K151964)
- Ci-Trol Coagulation Control III (K771346)
- Sysmex Automated Blood Coagulation Analyzer CS-2500 (K172286)
- Sysmex XN-11 (K141681)
- Sysmex XN 9000 (K112605)
- Sysmex XS-1000i (K081610)
Related Devices
- K151964 — Xprecia Stride Coagulation System, Xprecia System PT Controls · Siemens Healthcare Diagnostics · Sep 30, 2016
- K201185 — microINR System · Iline Microsystems, S.L. · Dec 18, 2020
Submission Summary (Full Text)
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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)
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.
| Type of Use (Select one or both, as applicable) | | | | | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--|---------------------------------------------|--|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span> <tr><td> Prescription Use (Part 21 CFR 801 Subpart D) </td><td></td></tr> <tr><td> Over-The-Counter Use (21 CFR 801 Subpart C) </td><td></td></tr> </span> | 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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#### Table of Contents
| 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 Ltd<br>1 Corporate Avenue, Rowville,<br>Victoria, 3178,<br>Australia |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Primary 510(k) Contact:<br>Nick Bliesner<br>Head of Operations<br>Universal Biosensors Pty Ltd<br>1 Corporate Avenue, Rowville,<br>Victoria, 3178,<br>Australia<br>Phone: +61 422475767<br>e-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.
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.
#### 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™ Coagulation<br>System, which includes the INR<br>Coagulation Analyzer (Meter) and<br>PT/INR Test Strips, is for the<br>determination of International<br>Normalized Ratio (INR) for the<br>monitoring of oral anticoagulation<br>therapy with Warfarin (a vitamin K<br>antagonist) in fresh capillary whole<br>blood from a fingerstick. The results<br>are reported in INR as well as in<br>seconds. It is intended to be used to<br>monitor patients 18 years of age or<br>older who are stable on vitamin K<br>antagonist therapy for at least six<br>weeks and is not intended for use in<br>patients who are transitioning from<br>heparin treatment to vitamin K<br>antagonist therapy. The Xprecia<br>Prime™ Coagulation System is an<br>in-vitro diagnostic device intended<br>for multi-patient use in professional<br>healthcare settings including CLIA<br>Waived and Point of care settings. | The CoaguChek® XS System is<br>intended for use by professional<br>healthcare providers for<br>quantitative prothrombin time<br>testing for the monitoring of<br>warfarin therapy. The<br>CoaguChek® XS System uses<br>fresh capillary or non-<br>anticoagulated venous whole<br>blood. |
| Measuring Range | 0.8 to 8.0 INR | Same |
| Closed System | The Xprecia Prime™ Coagulation<br>System, use Instrument and reagent<br>strips that are provided by UBI and<br>are intended to be used together. | The CoaguChek® XS System, use<br>Instrument and reagent strips that<br>are provided by Roche and are<br>intended to be used together. |
| Specimen Type | Capillary whole blood | Capillary whole blood and non-<br>anticoagulated venous whole<br>blood |
| Minimum Sample Volume | 8 µL | 10 µL |
| Operating Principle/Technology | Electrochemical technology with<br>amperometric (electric current)<br>detection of thrombin activity | Same |
| Characteristics | New Device<br>Xprecia PrimeTM Coagulation System | Predicate<br>CoaguChek® XS System |
| Test Strip Reagent | Human recombinant thromboplastin | Same |
| Electronic On-board Quality Control | Bi-level on-board quality control checks<br>to verify test strip integrity | Same |
| Strip Calibration | Each lot of test strips is calibrated to a<br>reference lot traceable to the WHO<br>International Reference Preparation | Same |
| Operating<br>Temperature | 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 % do<br>not significantly affect test results | Same |
| External Liquid<br>Quality Control<br>(LQC) | Liquid quality control in the normal and<br>therapeutic range (Optional) | No external liquid quality control |
| Test Strip Stability | 24 months | 21 months |
| Memory | 640 patient results<br>300 LQC results<br>300 system messages | 300 test results with date & time |
| Heparin | Warfarin patient test results are unaffected<br>by heparin concentrations up to 3 U/mL | Warfarin patient test results are<br>unaffected by heparin concentrations<br>up to 0.8 U/mL |
| Low Molecular<br>Weight Heparin | Test is insensitive to low molecular<br>weight heparin (LMWH) up to 3 IU anti-<br>factor Xa activity/mL | Insensitive to low molecular weight<br>heparins up to 2 IU anti factor Xa<br>activity/mL. |
| Capillary Accuracy<br>(All Sites) | Capillary blood on Xprecia PrimeTM<br>Coagulation System vs. venous plasma on<br>a Sysmex® CS 2500 laboratory analyzer<br>using Dade® Innovin®<br>N=381<br>y= 1.10 x -0.1<br>Correlation: 0.97 | Capillary blood on CoaguChek® XS<br>vs. venous plasma on a Sysmex<br>Analyzer using Dade Innovin (ISI =<br>1.02)<br>N=700<br>y=1.006x + 0.032<br>Correlation: 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.
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.
#### 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
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.
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™<br>Range | CoaguChek® | Slope<br>(95%CI) | Intercept<br>(95%CI) | (r) |
| Capillary | 401 | 9.7-91.6 | 10.5-96.0 | 0.962<br>(0.940,0.985) | -0.131<br>(-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 | Xprecia<br>Prime™ Range | Sysmex® Range | Slope<br>(95%CI) | Intercept<br>(95%CI) | (r) |
|-----|-------------------------|---------------|----------------------|---------------------------|------|
| 397 | 0.8-7.7 | 0.9-7.2 | 1.1<br>(1.073,1.117) | -0.12<br>(-0.183, -0.056) | 0.98 |
| Method Comparison Results for Xprecia Prime™ Coagulation System Vs Sysmex® CS-2500-PT seconds | | | | | |
|-----------------------------------------------------------------------------------------------|-------------------------|---------------|----------------------|--------------------------|------|
| N | Xprecia<br>Prime™ Range | Sysmex® Range | Slope<br>(95%CI) | Intercept<br>(95%CI) | (r) |
| 397 | 9.7-95.5 | 9.55-72.6 | 1.307<br>(1.28,1.33) | -2.341<br>(-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.
