(358 days)
Not Found (Manufacturer's name and model: Sysmex® CS 2500 laboratory analyzer)
No
The description focuses on a standard coagulation analysis method based on detecting clotting time, with no mention of AI/ML terms or methodologies.
No
The device is an in-vitro diagnostic device used to monitor oral anticoagulation therapy, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device..." and describes its purpose as determining the Normalized Ratio (INR) for monitoring oral anticoagulation therapy.
No
The device description explicitly states it includes both a hardware component (Analyzer) and a consumable component (Test Strips) in addition to any potential software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
N/A
Intended Use / Indications for 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.
Product codes
GJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood from a fingerstick
Indicated Patient Age Range
patients 18 years of age or older
Intended User / Care Setting
professional healthcare settings including CLIA Waived and Point of care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 1: Mean INR 1.18, Repeatability SD 0.03, Repeatability CV (%) 2.2
LQC Level 2: Mean INR 2.81, Repeatability SD 0.03, Repeatability CV (%) 1.0
LQC Level 3: Mean INR 6.52, Repeatability SD 0.07, Repeatability CV (%) 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 1: Mean INR 1.19, Repeatability SD 0.02, Repeatability CV (%) 2.0
LQC Level 2: Mean INR 2.62, Repeatability SD 0.03, Repeatability CV (%) 1.3
Repeatability: Capillary repeatability for duplicate results from each enrolled subject demonstrated an overall CV
§ 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).
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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
1
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
2
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) | 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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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
1 Corporate Avenue, Rowville,
Victoria, 3178,
Australia |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Primary 510(k) Contact:
Nick Bliesner
Head of Operations
Universal Biosensors Pty Ltd
1 Corporate Avenue, Rowville,
Victoria, 3178,
Australia
Phone: +61 422475767
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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Image /page/8/Picture/0 description: The image shows a logo with two distinct elements. On the left, there is a curved, gray shape that resembles a stylized letter 'U' or a crescent. To the right of this gray shape, there is a solid red circle or drop shape. The red element is positioned slightly above the gray shape, creating a visual balance in the logo.
| 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 | |
| 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 (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. | The CoaguChek® XS System is | |
| intended for use by professional | ||
| healthcare providers for | ||
| quantitative prothrombin time | ||
| testing for the monitoring of | ||
| warfarin therapy. The | ||
| CoaguChek® XS System uses | ||
| fresh capillary or non- | ||
| anticoagulated venous whole | ||
| blood. | ||
| Measuring Range | 0.8 to 8.0 INR | Same |
| Closed System | The Xprecia Prime™ Coagulation | |
| System, use Instrument and reagent | ||
| strips that are provided by UBI and | ||
| are intended to be used together. | The CoaguChek® XS System, use | |
| Instrument and reagent strips that | ||
| are provided by Roche and are | ||
| intended to be used together. | ||
| Specimen Type | Capillary whole blood | Capillary whole blood and non- |
| anticoagulated venous whole | ||
| blood | ||
| Minimum Sample Volume | 8 µL | 10 µL |
| Operating Principle/Technology | Electrochemical technology with | |
| amperometric (electric current) | ||
| detection of thrombin activity | Same | |
| Characteristics | New Device | |
| Xprecia PrimeTM Coagulation System | Predicate | |
| CoaguChek® XS System | ||
| Test Strip Reagent | Human recombinant thromboplastin | Same |
| Electronic On-board Quality Control | Bi-level on-board quality control checks | |
| to verify test strip integrity | Same | |
| Strip Calibration | Each lot of test strips is calibrated to a | |
| reference lot traceable to the WHO | ||
| International Reference Preparation | Same | |
| Operating | ||
| 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 | |
| not significantly affect test results | Same | |
| External Liquid | ||
| Quality Control | ||
| (LQC) | Liquid quality control in the normal and | |
| therapeutic range (Optional) | No external liquid quality control | |
| Test Strip Stability | 24 months | 21 months |
| Memory | 640 patient results | |
| 300 LQC results | ||
| 300 system messages | 300 test results with date & time | |
| Heparin | Warfarin patient test results are unaffected | |
| by heparin concentrations up to 3 U/mL | Warfarin patient test results are | |
| unaffected by heparin concentrations | ||
| up to 0.8 U/mL | ||
| Low Molecular | ||
| Weight Heparin | Test is insensitive to low molecular | |
| weight heparin (LMWH) up to 3 IU anti- | ||
| factor Xa activity/mL | Insensitive to low molecular weight | |
| heparins up to 2 IU anti factor Xa | ||
| activity/mL. | ||
| Capillary Accuracy | ||
| (All Sites) | Capillary blood on Xprecia PrimeTM | |
| Coagulation System vs. venous plasma on | ||
| a Sysmex® CS 2500 laboratory analyzer | ||
| using Dade® Innovin® | ||
| N=381 | ||
| y= 1.10 x -0.1 | ||
| Correlation: 0.97 | Capillary blood on CoaguChek® XS | |
| vs. venous plasma on a Sysmex | ||
| Analyzer using Dade Innovin (ISI = | ||
| 1.02) | ||
| N=700 | ||
| y=1.006x + 0.032 | ||
| Correlation: 0.971 |
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Image /page/9/Picture/0 description: The image shows a logo with two distinct elements. On the left, there is a curved, gray shape that resembles a stylized letter 'U' or a crescent. To the right of this shape, there is a solid red teardrop or oval shape. The logo has a simple and modern design, using contrasting colors and shapes to create a visually appealing image.
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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