(442 days)
Not Found
No
The document mentions an "algorithm" for determining clot time, but there is no mention of AI, ML, or any related technologies like neural networks or deep learning. The description of the device and performance studies focuses on standard analytical methods and comparisons to predicate and reference devices.
No
The device is an in vitro diagnostic medical device used for monitoring oral anticoagulation therapy. It provides diagnostic information (INR based on prothrombin time) but does not directly treat or prevent disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is intended for in vitro diagnostic use at the point-of-care." The "Device Description" section further reiterates, "The Xprecia Stride™ Coagulation System is an in vitro diagnostic medical device." This confirms its purpose is for diagnosis.
No
The device description explicitly states that the system consists of a "hand-held analyzer" and "single-use PT/INR test strips," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended for in vitro diagnostic use at the point-of-care." and "This product is for in vitro diagnostic use." for the strips and controls.
- Device Description: The "Device Description" section also states: "The Xprecia Stride™ Coagulation System is an in vitro diagnostic medical device..."
- Function: The device measures the prothrombin time (PT) and calculates the International Normalized Ratio (INR) from a blood sample. This is a diagnostic test performed in vitro (outside the body) to monitor a patient's response to warfarin therapy.
- Components: The system includes an analyzer, test strips, and controls, all of which are typical components of an IVD system.
N/A
Intended Use / Indications for Use
The Xprecia Stride™ Coagulation System, which includes the Xprecia Stride™ Coagulation Analyzer and the Xprecia™ System PT/INR Strips.is intended for use by professional healthcare provide an INR (International Normalized Ratio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin, a vitamin K antagonist. The Xprecia Stride™ Analyzer is intended to be used with only the Xprecia™ System PT/INR Strips and the Xprecia™ System PT Controls. The analyzer uses fresh capillary (fingerstick) whole blood applied to an Xprecia™ Strip. It is intended for in vitro diagnostic use at the point-of-care.
Xprecia™ System PT/INR Strips are for use with only the Xprecia Stride™ Coagulation Analyzer for PT/INR determinations by professional healthcare providers. This product is for in vitro diagnostic use.
Xprecia™ System PT Controls is a combination package containing lyophilized normal and therapeutic plasma controls for use with Xprecia™ Coagulation System for PT/INR determinations by professional healthcare providers. This product is for in vitro diagnostic use.
The Xprecia Stride™ Coagulation Systemis intended for use in patients 18 years of age and older. Patients must be stabilized (>6 weeks) on warfarin therapy. The Xprecia Stride™ Coagulation System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
Product codes (comma separated list FDA assigned to the subject device)
GJS, GGN
Device Description
The Xprecia Stride™ Coagulation System is an in vitro diagnostic medical device that is used to provide an INR (International Normalized Ratio) based on a prothrombin time (PT) response in whole blood and is intended for point of care professional use for the monitoring of warfarin (sold under Coumadin® and other brand names) therapy. The Xprecia Stride™ Coagulation System consists of a hand-held analyzer, Xprecia Stride™ Coagulation Analyzer, used in combination with single-use PT/INR test strips, Xprecia™ System PT/INR Strips, and Liquid Quality Controls (LQC), Xprecia™ System PT Controls.
The XpreciaT™ System PT/INR Strip contains the Dade® Innovin® reagent which is a preparation of purified recombinant human tissue factor combined with synthetic phospholipids, calcium chloride, and stabilizers. When a blood sample is applied to the test strip target area, the blood mixes with reagents and activates the coagulation cascade. The clot time is determined by an algorithm and the result is displayed as INR.
The XpreciaTM System PT Controls kit contains assayed Liquid Quality Controls for the assessment of precision and analytical bias in the normal (PT Control 1) and therapeutic (PT Control 2) ranges for the International Normalized Ratio (INR) to be used with the Xprecia™ System PT/INR Strips and Xprecia Stride™ Coagulation Analyzer. The controls consist of lyophilized human plasma, buffers and stabilizers. A Calcium Chloride diluent present in the kit is used to reconstitute the lyophilized control to activate the clotting process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age and older
Intended User / Care Setting
professional healthcare providers, point-of-care
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)
1. Analytical Performance
- a) Precision / Repeatability: Whole blood precision (Repeatability) across the measuring range was determined for fingerstick (capillary) samples by analyzing them in duplicate. Repeatability was evaluated across four (4) intended use sites using three (3) lots of PT/INR test strips per site. The study was executed by a total of fourteen (14) operators (minimum of three (3) at each site). The acceptance criterion of ≤10% CV across the measuring range was met.
- Reproducibility / Intermediate Precision: Reproducibility was determined by analyzing three (3) lots of Xprecia™ System PT Controls (PT Control 1 and PT Control 2) for 20 operational days, with 2 runs a day and 2 replicates per run for each control across four (4) intended use sites and using three (3) lots of Xprecia™ System PT/INR test strips. The study was executed by a total of twelve (12) operators (three (3) at each site).
- b) Linearity/assay reportable range: Not applicable for linearity. The assay reportable range (0.8 – 4.5 INR) was established through method comparison studies against the predicate (Roche CoaguChek® XS System) and the reference device (Siemens BCS XP laboratory analyzer).
- c) Traceability, Stability, Expected values:
- Traceability: Each lot of Xprecia™ System PT/INR test strips is factory calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation.
- Closed Vial Stability: 24 months shelf life at 5-30°C up to 75% Relative Humidity (RH); tested with three (3) lots over 105 weeks.
- Open Vial Stability: 2 months when stored between 5-30°C at up to 75 % RH; substantiated by testing three (3) lots over 69 days, opening 25 times.
- Out of Vial Stability: 5 minutes; established by testing three (3) lots exposed to high temperature and humidity for various times up to 12.5 minutes.
- Transport Stability: Evaluated three (3) lots under simulated transport conditions and freeze/thaw cycles.
- Xprecia™ System PT Controls Stability: 12 months shelf life from manufacturing for controls and reconstitution buffer. Reconstituted control solution stable for 60 minutes at 2-8℃ and 25 minutes at 15-25°C.
- Value Assignment: Performed by using three (3) vials of PT Controls from the same lot with three (3) Xprecia™ System PT/INR test strip lots on three (3) Xprecia Stride™ Coagulation Analyzers, in two single determinations (18 results per control level).
- d) Detection Limit (Factor sensitivity): Assessed for coagulation factors II (
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of what appears to be a family.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2016
Siemens Healthcare Diagnostics Noor Malki Vice President, Quality Management 2 Edgewater Drive Norwood. MA 02062
Re: K151964
Trade/Device Name: Xprecia Stride™ Coagulation System Xprecia™ System PT Controls Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time test Regulatory Class: Class II Product Code: GJS, GGN Dated: September 26, 2016 Received: September 27, 2016
Dear Ms. Malki:
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 (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. 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.
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 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS. MBA. MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151964
Device Name Xprecia StrideTM Coagulation System Xprecia™ System PT Controls
Indications for Use (Describe)
The Xprecia Stride™ Coagulation System, which includes the Xprecia Stride™ Coagulation Analyzer and the Xprecia™ System PT/INR Strips.is intended for use by professional healthcare provide an INR (International Normalized Ratio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin, a vitamin K antagonist. The Xprecia Stride™ Analyzer is intended to be used with only the Xprecia™ System PT/INR Strips and the Xprecia™ System PT Controls. The analyzer uses fresh capillary (fingerstick) whole blood applied to an Xprecia™ Strip. It is intended for in vitro diagnostic use at the point-of-care.
Xprecia™ System PT/INR Strips are for use with only the Xprecia Stride™ Coagulation Analyzer for PT/INR determinations by professional healthcare providers. This product is for in vitro diagnostic use.
Xprecia™ System PT Controls is a combination package containing lyophilized normal and therapeutic plasma controls for use with Xprecia™ Coagulation System for PT/INR determinations by professional healthcare providers. This product is for in vitro diagnostic use.
The Xprecia Stride™ Coagulation Systemis intended for use in patients 18 years of age and older. Patients must be stabilized (>6 weeks) on warfarin therapy. The Xprecia Stride™ Coagulation System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1.0 Submitter Information
| Owner | Siemens Healthcare Diagnostics, Inc.
2 Edgewater Drive
Norwood, MA 02062 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Noor Malki
VP Clinical, Medical, Regulatory & Quality Operations
Siemens Healthcare Diagnostics
Point of Care (POC) Business
noor.malki@siemens.com
TEL 781-269-3401 |
| Date Summary Prepared | September 30, 2016 |
2.0 Device Information
| Proprietary Name | Xprecia Stride™ Coagulation System
Xprecia™ System PT Controls |
|------------------|-------------------------------------------------------------------|
| Common Name | Prothrombin time test |
| Panel | Hematology |
Regulatory Information:
| Classification | |||||
|---|---|---|---|---|---|
| Device | Regulation | ||||
| Section | Device | ||||
| Class | Product | ||||
| Code | Test | ||||
| Xprecia Stride™™ | |||||
| Coagulation | |||||
| System | 21 CFR 864.7750 | II | GJS | Prothrombin time test | |
| Xprecia™™ System | |||||
| PT Controls | 21 CFR 864.5425 | II | GGN | Plasma, coagulation control |
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3.0 Substantial Equivalence Information
| Element | Predicate device |
|---|---|
| Predicate Device Name | CoaguChek® XS System |
| Common Name | Prothrombin time test |
| 510(k) Number | K060978 |
| Manufacturer | Roche Diagnostics |
4.0 Device Description
The Xprecia Stride™ Coagulation System is an in vitro diagnostic medical device that is used to provide an INR (International Normalized Ratio) based on a prothrombin time (PT) response in whole blood and is intended for point of care professional use for the monitoring of warfarin (sold under Coumadin® and other brand names) therapy. The Xprecia Stride™ Coagulation System consists of a hand-held analyzer, Xprecia Stride™ Coagulation Analyzer, used in combination with single-use PT/INR test strips, Xprecia™ System PT/INR Strips, and Liquid Quality Controls (LQC), Xprecia™ System PT Controls.
The XpreciaT™ System PT/INR Strip contains the Dade® Innovin® reagent which is a preparation of purified recombinant human tissue factor combined with synthetic phospholipids, calcium chloride, and stabilizers. When a blood sample is applied to the test strip target area, the blood mixes with reagents and activates the coagulation cascade. The clot time is determined by an algorithm and the result is displayed as INR.
The XpreciaTM System PT Controls kit contains assayed Liquid Quality Controls for the assessment of precision and analytical bias in the normal (PT Control 1) and therapeutic (PT Control 2) ranges for the International Normalized Ratio (INR) to be used with the Xprecia™ System PT/INR Strips and Xprecia Stride™ Coagulation Analyzer. The controls consist of lyophilized human plasma, buffers and stabilizers. A Calcium Chloride diluent present in the kit is used to reconstitute the lyophilized control to activate the clotting process.
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5.0 Indications for Use / Intended Use
The Xprecia Stride™ Coagulation System, which includes the Xprecia Stride™ Coagulation Analyzer and the Xprecia™ System PT/INR Strips, is intended for use by professional healthcare providers to provide an INR (International Normalized Ratio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin, a vitamin K antagonist. The Xprecia Stride™ Coagulation Analyzer is intended to be used with only the Xprecia™ System PT/INR Strips and the Xprecia™ System PT Controls. The analyzer uses fresh capillary (fingerstick) whole blood applied to an Xprecia™ System PT/INR Strip. It is intended for in vitro diagnostic use at the point-of-care.
Xprecia™ System PT/INR Strips are for use with only the Xprecia Stride™ Coagulation Analyzer for PT/INR determinations by professional healthcare providers. This product is for in vitro diagnostic use.
Xprecia™ System PT Controls is a combination package containing lyophilized normal and therapeutic plasma controls for use with Xprecia™ Coaqulation System for PT/INR determinations by professional healthcare providers. This product is for in vitro diagnostic use.
The Xprecia Stride™ Coagulation System is intended for use in patients 18 years of age and older. Patients must be stabilized (>6 weeks) on warfarin therapy. The Xprecia Stride™ Coagulation System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
| Similarities | ||
|---|---|---|
| Item | Xprecia Stride™ Coagulation | |
| System (New device) | CoaguChek® XS System | |
| (Predicate) | ||
| Intended | ||
| Use/Indications for | ||
| Use | The Xprecia Stride™ Coagulation | |
| System, which includes the Xprecia | ||
| Stride™ Coagulation Analyzer and | ||
| the Xprecia™ System PT/INR | ||
| Strips, is intended for use by | ||
| professional healthcare providers to | ||
| provide an INR (International | ||
| Normalized Ratio) based on a | ||
| prothrombin time (PT) response for | ||
| the monitoring of oral | ||
| anticoagulation therapy with | ||
| warfarin, a vitamin K antagonist. | ||
| The Xprecia Stride™ Coagulation | ||
| Analyzer is intended to be used | ||
| with only the Xprecia™ System | ||
| PT/INR Strips and the Xprecia™ | ||
| System PT Controls. The analyzer | ||
| uses fresh capillary (fingerstick) | ||
| whole blood applied to an | ||
| Xprecia™ System PT/INR Strip. It | 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. | ||
| Similarities | ||
| Item | Xprecia Stride™ Coagulation | |
| System (New device) | CoaguChek® XS System | |
| (Predicate) | ||
| is intended for in vitro diagnostic | ||
| use at the point-of-care. | ||
| Xprecia™ System PT/INR Strips | ||
| are for use with only the Xprecia | ||
| Stride™ Coagulation Analyzer for | ||
| PT/INR determinations by | ||
| professional healthcare providers. | ||
| This product is for in vitro diagnostic | ||
| use. | ||
| Xprecia™ System PT Controls is a | ||
| combination package containing | ||
| lyophilized normal and therapeutic | ||
| plasma controls for use with | ||
| Xprecia™ Coagulation System for | ||
| PT/INR determinations by | ||
| professional healthcare providers. | ||
| This product is for in vitro diagnostic | ||
| use. | ||
| The Xprecia Stride™ Coagulation | ||
| System is intended for use in | ||
| patients 18 years of age and older. | ||
| Patients must be stabilized (>6 | ||
| weeks) on warfarin therapy. The | ||
| Xprecia Stride™ Coagulation | ||
| System is not intended for use in | ||
| patients who are transitioning from | ||
| heparin treatment to warfarin | ||
| therapy. | ||
| Sample Type | Capillary whole blood | Same and non- |
| anticoagulated venous | ||
| whole blood | ||
| Operating | ||
| Principle/Technology | Electrochemical technology with | |
| amperometric (electric current) | ||
| detection of thrombin activity | Same | |
| Test Strip Reagent | Human recombinant thromboplastin | Same |
| Low Molecular | ||
| Weight Heparin | Test is insensitive to low molecular | |
| weight heparin (LMWH) up to 2 IU | ||
| anti-factor Xa activity/mL | 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 | Same |
| Similarities | ||
| Item | Xprecia Stride™ Coagulation | |
| System (New device) | CoaguChek® XS System | |
| (Predicate) | ||
| to a reference lot traceable to the | ||
| WHO International Reference | ||
| Preparation | ||
| Reference Range | INR: 0.9 to 1.1 | Same |
6.0 Summary Comparison of Technological Characteristics (Predicate)
6
6.0 Summary Comparison of Technological Characteristics (Predicate)
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6.0 Summary Comparison of Technological Characteristics (Predicate)
| Differences | ||
|---|---|---|
| Item | Xprecia Stride™ Coagulation System (New device) | CoaguChek® XS System (Predicate) |
| Test Strip Use Time | Within 5 minutes of removing from vial | Within 10 minutes of removing from vial** |
| External Liquid Quality Control | Liquid quality control in the normal and therapeutic range. | No external liquid quality control** |
| Minimum Sample Volume | 6 μL | ≥8 μL* |
| Memory | 640 patient results | |
| 300 LQC results | ||
| 300 system messages | 300 test results** | |
| Heparin | Warfarin patient test results are unaffected by heparin concentrations up to 3U/mL | Warfarin patient test results are unaffected by heparin concentrations up to 0.8U/mL |
| Test Strip Stability | 24 months | 21 months |
| Operating Temperature | 15 – 35°C (59 – 95°F) | 15 – 32°C (59 – 90°F)** |
| Hematocrit Range | Hematocrit range between 22 – 52% do not significantly affect test results | Hematocrit range between 25 – 55% do not significantly affect test results* |
| Measuring Range | 0.8 to 4.5 INR | 0.8 to 8.0 INR |
| Built-in barcode reader | Enables automatic entry of strip calibration, lot number and expiration date by reading the 2D barcode on the test strip vial | None |
- Per the CoaguChek® PT Test Instructions for Use
**Per the CoaguChek® XS System User Manual
8
7.0 Standard/Guidance Document referenced (if applicable):
CLSI EP05-A2 - Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition
CLSI EP05-A3 – Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
CLSI EP09-A3 – Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Third Edition
CLSI EP07-A2 - Interference Testing in Clinical Chemistry; Approved Guideline -Second Edition
CLSI EP14-A3 - Evaluation of Commutability of Process Samples; Approved Guideline - Third Edition
8.0 Test Principle
The Xprecia Stride™ Coagulation System is a handheld in vitro diagnostic medical device that uses electrochemical technology to measure the prothrombin time from a fresh capillary (fingerstick) whole blood sample. The fresh capillary (fingerstick) whole blood sample is applied to the Xprecia™ System PT/INR test strips for testing. The Xprecia™ System PT/INR Strip is inserted into the analyzer which applies a small voltage across the electrodes and measures any resulting electrical current as a function of time. A sample chamber in the test strip is filled with the blood sample by capillary action. The test strip contains Dade® Innovin® which is a preparation of purified recombinant human tissue thromboplastin, combined with synthetic phospholipids, calcium, stabilizers, and an electroactive thrombin substrate. An electroactive group released from the thrombin substrate is detected electrochemically at the electrodes in the test strip; the current produced is analyzed by an algorithm to determine the coagulation time. The analyzer displays the International Normalized Ratio (INR) on the screen.
9.0 Performance Characteristics
1. Analytical Performance
- a) Precision / Repeatability:
Whole blood precision (Repeatability) across the measuring range was determined for fingerstick (capillary) samples by analyzing them in duplicate. Repeatability was evaluated across four (4) intended use sites using three (3) lots of PT/INR test strips per site. The study was executed by a total of fourteen (14) operators (minimum of three (3) at each site). The table below shows the repeatability results for combined sites. The acceptance criterion of ≤10% CV across the measuring range was met.
9
| Site/INR Range
(BCS XP) | ) reconstitution buffer. The shelf life for PT Control 1, PT Control 2 and the reconstitution buffer was established as 12 months from the date of manufacture. The stability of the reconstituted control solution was established as 60 minutes when stored at 2-8℃, and 25 minutes when stored at 15-25°C.
Value Assignment
Value assignment was performed by using three (3) vials of PT Controls (PT Control 1 and PT Control 2) from the same lot with three (3) Xprecia™ System PT/INR test strip lots on three (3) Xprecia Stride™ Coagulation Analyzers, in two single determinations. This resulted in 18 results for each control level (3 vials x 2 determinations x 3 analyzers/ strip lot combinations).
The mean of the 18 determinations are to be considered as the assigned value for the PT Control.
- d) Detection Limit:
Factor sensitivity was assessed for coagulation factors II, V, VII, and X. The Factor Sensitivity was determined using nine (9) Xprecia Stride™ Coagulation Analyzers, three (3) lots of Xprecia™ System PT/INR test strips, and normal human red blood cells mixed with various concentrations of normal human plasma and the applicable factor deficient plasma. Each level of Factor Sensitivity was carried out twice on each analyzer. The study verifies Factor Sensitivity for the Xprecia™ System PT/INR test strips at the following levels (% of normal factor level; in vitro testing): Factor II