(269 days)
Not Found
No
The description details a standard electrochemical measurement and algorithmic conversion, with no mention of AI or ML terms or concepts.
No
The device measures INR to monitor the effect of a therapy, it does not administer or directly provide therapy itself.
Yes
The device measures an INR (International Normalized Ratio) to monitor the effect of a therapy, which is a key function of a diagnostic device as it provides information about a patient's health status related to their treatment.
No
The device description explicitly states that the CoaguChek Vantus consists of a handheld meter and associated test strips, which are hardware components. The software is part of the meter's functionality but the device itself is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system "measures an INR (International Normalized Ratio) based on a prothrombin time (PT) response to monitor the effect of a therapy with vitamin K antagonists by using the CoaguChek XS PT test strips." This involves testing a biological sample (fresh capillary whole blood) in vitro (outside the body) to provide diagnostic information (monitoring the effect of therapy).
- Device Description: The description details how the test strip and meter work together to analyze the blood sample and generate a result. This process is performed in vitro.
- Sample Type: The device uses "fresh capillary whole blood from a finger stick," which is a biological specimen.
- Performance Studies: The performance studies describe analytical and clinical evaluations of the device's ability to accurately measure INR from blood samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The CoaguChek® Vantus System measures an INR (International Normalized Ratio) based on a prothrombin time (PT) response to monitor the effect of a therapy with vitamin K antagonists by using the CoaguChek XS PT test strips. The CoaguChek Vantus System uses fresh capillary whole blood from a finger stick.
The system is intended for properly selected and suitable trained users on the treating doctor.
Users should be stabilized on anticoagulation with vitamin K antagonists for at least 6 weeks prior to single patient selftesting with the CoaguChek Vantus System.
The CoaguChek Vantus System is intended for single patient self-testing only for adults, age 22 years and older.
Product codes (comma separated list FDA assigned to the subject device)
GJS
Device Description
The CoaguChek Vantus consists of a handheld meter and associated test strips.
The CoaguChek Vantus meter is a small handheld instrument intended for the quantitative measurement of INR (International Normalized Ratio) based on a prothrombin time (PT) response, by using a single electrochemical test strip. It is designed for ease of use and is intended for patient self-testing only.
The CoaguChek XS PT Test strip contains a lyophilized reagent in dried form). The reactive components of this reagent consist of thromboplastin and a peptide substrate. When a sample is applied, thromboplastin activates coagulation, which leads to the formation of thrombin. At the same time, the meter starts to measure the time. The enzyme thrombin cleaves the peptide substrate, generating an electrochemical signal. Depending on the time elapsed when it first appears, this signal is then converted by means of an algorithm into customary coagulation units and the result is displayed.
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
adults, age 22 years and older
Intended User / Care Setting
properly selected and suitable trained users on the prescription of the treating doctor.
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)
Non-Clinical Performance Evaluation:
- Endogenous Interferences Hematocrit/Bilirubin/Triglycerides/Hemolysis/Heparin.
- Exogenous Interferences Drugs.
- Stability.
Linearity/Assay Reportable Range:
- Linearity study is not applicable.
- Assay Reportable Range: The assay reportable range (0.8 - 6.0 INR) of the CoaguChek Vantus System was established through method comparison studies against both the predicate (Roche CoaguChek XS System) and the reference device (Sysmex CA-1500 laboratory analyzer). Dade Innovin Reagent was used for prothrombin time (PT) determinations.
Test Strip Stability:
- Traceability: Each lot of CoaguChek XS PT Test Strips is factory calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation.
- Closed Vial and Transport Stability: CoaguChek XS PT Test strips stored at +2-8 °C and +26-30°C and tested after 3, 6, 16, and 25 months. The 25 month time point also captured 5-day stressed storage at +45 °C (±2 °C).
- Open Vial Stability: Tested by opening vials once per day for at least 1 minute at +32 °C, 85 % relative humidity (RH) over a period of 30 days.
- Out of Vial Stability: Verified by storing the test strip outside the vial under specified environmental conditions for 14 minutes before measurement (+32 ℃, 85 % RH).
Detection Limit/Factor Sensitivity:
-
Four CoaguChek XS PT Test strip lots were used.
-
Standard human plasma mixed with varying amounts of factor II, V, VII or X deficient plasma to obtain plasma samples with different factor activities (0, 1, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100 %).
-
Factor sensitivities were calculated according to CLSI guidelines (CLSI H47-A2; Vol.28, Appendix D).
-
Verified Factor Sensitivity at: Factor II 3.5-4.5, >4.5 INR).
- Results:
- For 3.5 - 4.5 INR (N=70): Mean 4.0 INR, SD 0.12, CV 3.2%
- For > 4.5 - 6.0 INR (N=24): Mean 4.9 INR, SD 0.07, CV 1.5%
- Results:
-
Precision (Reproducibility):
- Intermediate precision experiment conducted at all 4 PoC sites, with three lots of CoaguChek XS PT Test strips.
- Data obtained from HCP measurements of three lots of CoaguChek XS PT controls covering four levels.
- Results (Reproducibility):
- Control Level 1 (N=1040): Mean 1.32, SD 0.05, % CV 4.0
- Control Level 2 (N=1040): Mean 2.79, SD 0.12, % CV 4.2
- Control Level 3 (N=708): Mean 5.85, SD 0.24, % CV 4.0
- Control Level 4 (N=712): Mean 3.39, SD 0.11, % CV 3.2
-
Method Comparison versus Predicate:
- Accuracy evaluated by comparing CoaguChek Vantus System against CoaguChek XS System (predicate).
- Clinical method comparison study performed using capillary whole blood samples from subjects not receiving warfarin or any other anticoagulant and from subjects on warfarin therapy.
- Conducted across 4 PoC sites using three CoaguChek XS PT Test strip lots.
- Results (All sites combined, N=207): Slope 1.00 (95% CI: 1.00, 1.03), Intercept 0.1 (95% CI: 0.1, 0.1), Pearson r 0.99.
-
Method Comparison versus Reference System:
- Accuracy evaluated by comparing INR results of capillary samples measured on CoaguChek Vantus System against INR of venous plasma samples measured on Sysmex CA 1500 laboratory analyzer using Dade Innovin recombinant human tissue thromboplastin reagent (reference device).
- Study performed across four (4) sites using CoaguChek XS PT Test strip lots.
- Passing-Bablok regression analysis performed on combined data.
- Results (All sites combined, N=200): Slope 0.98 (95% CI: 0.93, 1.03), Intercept 0.1 (95% CI: 0.0, 0.3), Pearson r 0.91.
-
Sample Matrix Comparison: Not applicable, as the CoaguChek Vantus System is intended for use with capillary whole blood samples only.
-
Expected Values / Reference Range:
- Normal range study conducted on 121 healthy subjects not on anticoagulation therapy.
- Capillary whole blood sample testing demonstrated that 95% of the INRs ranged between 0.9 - 1.1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CoaguChek XS System, K062925
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Sysmex CA-1500 laboratory analyzer (Note: K/DEN number not provided in the text).
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 25, 2017
Roche Diagnostics Justin Davis Regulatory Affairs Principal 9115 Hague Road Indianapolis, Indiana 46250
Re: K170960
Trade/Device Name: CoaguChek Vantus System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time test Regulatory Class: Class II Product Code: GJS Dated: November 24, 2017 Received: November 27, 2017
Dear Justin Davis:
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 Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170960
Device Name CoaguChek Vantus System
Indications for Use (Describe)
The CoaguChek® Vantus System measures an INR (International Normalized Ratio) based on a prothrombin time (PT) response to monitor the effect of a therapy with vitamin K antagonists by using the CoaguChek XS PT test strips. The CoaguChek Vantus System uses fresh capillary whole blood from a finger stick.
The system is intended for properly selected and suitable trained users on the treating doctor.
Users should be stabilized on anticoagulation with vitamin K antagonists for at least 6 weeks prior to single patient selftesting with the CoaguChek Vantus System.
The CoaguChek Vantus System is intended for single patient self-testing only for adults, age 22 years and older.
| 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
CoaguChek Vantus System 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the CoaguChek Vantus System.
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Justin Davis |
| Phone: (317) 521-6024 | |
| FAX: (317) 521-2324 | |
| Email: justin.davis@roche.com | |
| Date Prepared | March 30, 2017 |
| Proprietary Name | CoaguChek Vantus System |
| Common Name | CoaguChek Vantus System |
| Classification Name | Test Time Prothrombin |
| Prothrombin Time Test | |
| Product Codes, Regulation Numbers | GJS, 21 CFR 864.7750 |
| Predicate Devices | CoaguChek XS System, K062925 |
| Establishment Registration | For the CoaguChek Vantus System, the establishment registration |
| number for Roche Diagnostics GmbH in Mannheim, Germany is |
The establishment registration number for Roche Diagnostics in the
United States is 1823260. |
4
DEVICE DESCRIPTION 1.
1.1. CoaguChek Vantus System
The CoaguChek Vantus consists of a handheld meter and associated test strips.
The CoaguChek Vantus meter is a small handheld instrument intended for the quantitative measurement of INR (International Normalized Ratio) based on a prothrombin time (PT) response, by using a single electrochemical test strip. It is designed for ease of use and is intended for patient self-testing only.
1.2. CoaquChek XS PT Test Strip
The CoaguChek XS PT Test strip contains a lyophilized reagent in dried form). The reactive components of this reagent consist of thromboplastin and a peptide substrate. When a sample is applied, thromboplastin activates coagulation, which leads to the formation of thrombin. At the same time, the meter starts to measure the time. The enzyme thrombin cleaves the peptide substrate, generating an electrochemical signal. Depending on the time elapsed when it first appears, this signal is then converted by means of an algorithm into customary coagulation units and the result is displayed.
2. INTENDED USE
The CoaguChek® Vantus System measures an INR (International Normalized Ratio) based on a prothrombin time (PT) response to monitor the effect of a therapy with vitamin K antagonists by using the CoaguChek XS PT test strips. The CoaguChek Vantus System uses fresh capillary whole blood from a finger stick.
The system is intended for properly selected and suitable trained users on the prescription of the treating doctor.
Users should be stabilized on anticoagulation with vitamin K antagonists for at least 6 weeks prior to single patient self-testing with the CoaguChek Vantus System.
The CoaguChek Vantus System is intended for single patient self-testing only for adults, age 22 years and older.
5
TECHNOLOGICAL CHARACTERISTICS 3.
The following tables compare the CoaguChek Vantus System with its predicate device,
CoaguChek XS System (K062925).
| Candidate Device Name | Predicate Device Name | K-Number |
|---|---|---|
| CoaguChek Vantus System | CoaguChek XS System | K062925 |
Table 1: Instrument and Assay Comparison
| Feature | CoaguChek XS System (K062925) | CoaguChek Vantus System |
|---|---|---|
| Intended Use | The CoaguChek XS PT test strips are part of the | |
| CoaguChek XS System. The CoaguChek XS System | ||
| measures blood clotting time for people who are | ||
| taking anticoagulation medications such as | ||
| Coumadin® or warfarin. The CoaguChek XS System | ||
| uses blood from a finger stick. The system is | ||
| intended for properly selected and suitably trained | ||
| users or their caregivers on the prescription or | ||
| other order of the treating doctor. Users should be | ||
| stabilized on anticoagulation medications such as | ||
| Coumadin® or warfarin prior to self- testing with | ||
| the CoaguChek XS System. | The CoaguChek® Vantus System measures an INR | |
| (International Normalized Ratio) based on a | ||
| prothrombin time (PT) response to monitor the | ||
| effect of a therapy with vitamin K antagonists by | ||
| using the CoaguChek XS PT test strips. The | ||
| CoaguChek Vantus System uses fresh capillary | ||
| whole blood from a finger stick. | ||
| The system is intended for properly selected and | ||
| suitable trained users on the prescription of the | ||
| treating doctor. | ||
| Users should be stabilized on anticoagulation with | ||
| vitamin K antagonists for at least 6 weeks prior to | ||
| single patient self-testing with the CoaguChek | ||
| Vantus System. | ||
| The CoaguChek Vantus System is intended for | ||
| single patient self-testing only for adults, age 22 | ||
| years and older. | ||
| Indications for Use | Same as Intended Use | Same as Intended Use |
| Test Strip | CoaguChek XS PT Test Strip | Same |
| Sample Type | Capillary Whole Blood | Same |
| Operating Principle | Electrochemical technology with amperometric | |
| (electric current) detection of thrombin activity | Same | |
| Reagent Test Strip | ||
| Principle | Human recombinant thromboplastin | Same |
| Sample Volume | The blood drop must be a minimum of 8 µl | Same |
| Measuring Range | 0.8 to 8.0 INR | 0.8 to 6.0 INR |
| On-Board Control | Built into each CoaguChek XS PT Test Strip | Same |
| Hematocrit Range | Hematocrit ranges between 25-55% have no | |
| significant effect on test results | Same | |
| Bilirubin | Bilirubin up to 30 mg/dL have no significant effect | |
| on test results | Same |
6
| Feature | CoaguChek XS System (K062925) | CoaguChek Vantus System |
|---|---|---|
| Triglyceride | Lipemic samples containing up to 500 mg/dL of | |
| triglycerides have no significant effect on test | ||
| results | Same | |
| Hemolysis | Hemolysis up to 1000 mg/dL have no significant | |
| effect on test results | Same | |
| Heparin | Test results are unaffected by heparin | |
| concentrations up to 0.8 U/mL | Same | |
| Low Molecular | ||
| Weight Heparin | The CoaguChek XS PT Test is insensitive to low | |
| molecular weight heparins (LMWH) up to 2 IU anti- | ||
| factor Xa activity/mL | Same | |
| Memory Capacity | 300 test results with date and time | |
| No test strip lot information stored (code chip | ||
| data) | 300 test results with date and time | |
| Code chip data from up to 5 test strip lots can be | ||
| stored | ||
| Communication | ||
| Interface | Infrared | Bluetooth, USB |
NON-CLINICAL PERFORMANCE EVALUATION 4.
The following internal performance data were provided in support of the substantial equivalence determination:
- Endogenous Interferences Hematocrit/Bilirubin/Triglycerides/Hemolysis/Heparin .
- Exogenous Interferences Drugs .
- Stability .
4.1. Linearity/Assay Reportable Range
- 4.1.1. -Linearity
A linearity study is not applicable for the CoaguChek Vantus System.
4.1.2. Assay Reportable Range
The assay reportable range (0.8 - 6.0 INR) of the CoaguChek Vantus System was established through method comparison studies against both the predicate (Roche CoaguChek XS System) and the reference device (Sysmex CA-1500 laboratory analyzer). Dade Innovin Reagent was used for prothrombin time (PT) determinations.
7
Test Strip Stability 4.2.
4.2.1. Traceability
Each lot of CoaguChek XS PT Test Strips is factory calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation.
4.2.1.1. Closed Vial and Transport Stability
The CoaguChek XS PT Test strips were stored at +2-8 °C and +26-30°C and tested after a storage time of 3, 6, 16, and 25 months. The 25 month time point captures the component of transport stability, as the 25 months includes a 5-day period of stressed storage at +45 °C (±2 °C).
4.2.1.2. Open Vial Stability
Open vial stability simulates the repeated opening and closing of the vial by the customer when strips are removed from the vial for measurement. Open vial stability was tested by opening the vials once per day for at least 1 minute at +32 °C, 85 % relative humidity (RH) over a period of 30 days.
4.2.1.3. Out of Vial Stability
Out of vial stability was tested to prove that the test strips can be kept outside the vial before measurement for at least 10 minutes when directly exposed to +32 ℃, 85 % RH. This was verified by storing the test strip outside the vial under the specified environmental conditions for 14 minutes before measurement
Detection Limit/Factor Sensitivity 4.3.
For Factor Sensitivity studies, four CoaguChek XS PT Test strip lots were used.
Standard human plasma was mixed with varying amounts of factor II, V, VII or X deficient plasma to obtain plasma samples with different factor activities (0, 1, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100 %). For each test strip lot, at least 4 measurements were performed per coagulation factor and dilution level.
8
Factor sensitivities were calculated according to CLSI guidelines (CLSI H47-A2; Vol.28, Appendix D). The study verifies Factor Sensitivity at the following levels: Factor II 3.5-4.5, >4.5 INR).
| Blood | 3.5 - 4.5 INR | > 4.5 - 6.0 INR |
|------------|-----------|-------------|-----------------|-----------------|
| N | 200 | 394 | 70 | 24 |
| Mean (INR) | 1.1 | 2.6 | 4.0 | 4.9 |
| SD (INR) | 0.04 | 0.08 | 0.12 | 0.07 |
| CV (%) | 3.8 | 3.1 | 3.2 | 1.5 |
Summary of Repeatability for CoaguChek Vantus Table 2:
5.1.2. Reproducibility
The intermediate precision experiment according to the CLSI Guideline EP05-A3 was conducted at all 4 PoC sites, with three lots of CoaguChek XS PT Test strips. The data was obtained from HCP measurements of three lots of CoaguChek XS PT controls covering four levels of controls.
Table 3: Summary of Reproducibility for CoaguChek Vantus
| | | Repeatability
(Within Run) | | Between
Run | | Between
Strip Lot | | Between
Day | | Between
Site | | Reproducibility | | |
|------------------|------|-------------------------------|------|----------------|------|----------------------|------|----------------|------|-----------------|------|-----------------|------|------|
| Control
Level | N | Mean | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| 1 | 1040 | 1.32 | 0.03 | 2.4 | 0.01 | 0.6 | 0.04 | 2.9 | 0.01 | 0.7 | 0.01 | 1.0 | 0.05 | 4.0 |
| 2 | 1040 | 2.79 | 0.11 | 4.0 | 0.00 | 0.0 | 0.02 | 0.7 | 0.00 | 0.0 | 0.03 | 1.0 | 0.12 | 4.2 |
| 3 | 708 | 5.85 | 0.17 | 2.9 | 0.07 | 1.2 | 0.14 | 2.3 | 0.04 | 0.8 | 0.02 | 0.4 | 0.24 | 4.0 |
| 4 | 712 | 3.39 | 0.09 | 2.7 | 0.04 | 1.2 | 0.03 | 1.0 | 0.00 | 0.0 | 0.03 | 0.9 | 0.11 | 3.2 |
10
Method Comparison 5.2.
5.2.1. Method Comparison versus Predicate
Accuracy was evaluated by comparing the CoaguChek Vantus System against the predicate device, the CoaguChek XS System. The clinical method comparison study was performed using capillary whole blood samples from subjects not receiving warfarin or any other anticoagulant and from subjects currently on warfarin therapy. The method comparison study was conducted across 4 PoC sites using three 3 CoaguChek XS PT Test strip lots.
Table 4: CoaguChek Vantus System vs CoaguChek XS System
| Site | N | Slope
(95% CI) | Intercept
(95% CI) | Pearson
r |
|------|-----|----------------------|-----------------------|--------------|
| All | 207 | 1.00
(1.00, 1.03) | 0.1
(0.1, 0.1) | 0.99 |
5.2.2. Method Comparison versus Reference System
Accuracy was also evaluated by comparing the INR results of capillary samples measured on the CoaguChek Vantus System against the INR of venous plasma samples measured on Sysmex CA 1500 laboratory analyzer using Dade Innovin recombinant human tissue thromboplastin reagent (reference device). The method comparison study was performed s across four (4) sites using CoaguChek XS PT Test strip lots. Results of INR values measured on CoaguChek Vantus System fingerstick capillary whole blood samples were compared to the INR measured on Innovin using venous plasma samples. The data from individual sites were combined and a Passing-Bablok regression analysis was performed.
Table 5: CoaguChek Vantus System vs Innovin
| Site | N | Slope
(95% CI) | Intercept
(95% CI) | Pearson r |
|------|----|---------------------|-----------------------|-----------|
| 1 | 67 | 0.94
(0.85,1.02) | 0.2
(-0.0,0.4) | 0.86 |
| 2 | 43 | 1.02
(0.92,1.15) | 0.1
(-0.2,0.3) | 0.97 |
| 3 | 47 | 1.03
(0.94,1.12) | 0.0
(-0.2,0.2) | 0.97 |
11
| Site | N | Slope
(95% CI) | Intercept
(95% CI) | Pearson r |
|------|-----|----------------------|-----------------------|-----------|
| 4 | 43 | 0.95
(0.82,1.13) | 0.2
(-0.3,0.5) | 0.93 |
| All | 200 | 0.98
(0.93, 1.03) | 0.1
(0.0, 0.3) | 0.91 |
5.3. Sample Matrix Comparison
Not applicable, as the CoaguChek Vantus System is intended for use with capillary whole blood samples only.
5.4. Expected Values / Reference Range
A normal range study was conducted on 121 healthy subjects not on anticoagulation therapy. Capillary whole blood sample testing performed on the subjects not using vitamin K antagonist drugs demonstrated that 95% of the INRs ranged between 0.9 - 1.1.
6. SYSTEM DESCRIPTIONS
6.1. Modes of Operation
The CoaguChek Vantus System is a closed system, which only uses the CoaguChek XS PT Test Strip; other test strips will not work with the instrument.
6.2. Software
The user interface of the CoaguChek Vantus instrument guides the user through the test procedure step by step. The user only needs to insert the code chip, turn the meter on, insert the test strip, and apply a blood sample. The CoaguChek Vantus meter measures the coagulation time and displays the result. After the test is completed, the meter automatically saves the test result.
The system also includes Bluetooth connectivity to allow transfer of INR results.
12
Specimen Sampling and Handling 6.3.
The CoaguChek XS PT Test strip is intended for single-use only. Once the test strip is inserted into the analyzer, a drop of fresh capillary whole blood sample collected by fingerstick is manually applied to the test strip target area and analyzed by the CoaguChek Vantus instrument.
6.4. Calibration
Each lot of CoaguChek XS PT Test strips is factory calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization International Reference Preparation. This lot-specific calibration information is embedded within the code chip, which is required by the CoaguChek Vantus instrument prior to using the specific lot of the CoaguChek XS PT Test strip.
Quality Control 6.5.
The CoaguChek Vantus System provides On-Board Controls (OBC), which provide a quality control check for each individual CoaguChek XS PT Test strip used with the CoaguChek Vantus instrument. There are no additional steps required by the user to activate the OBC.
When a test strip is inserted, the CoaguChek Vantus instrument, the first check assesses potential issues with the reagent. The second check ensures that the test strip has not been exposed to environmental conditions or physical stresses, like bending. If either of these checks does not pass, then no PT/INR result is provided.
CONCLUSIONS 7.
The submitted information in this premarket notification supports a substantial equivalence decision.
The results of these studies demonstrate that the CoaguChek Vantus System is similar to the predicate. The data presented are a summary of external clinical evaluation, internal laboratory evaluation, and software development information.