(231 days)
Unknown
The document mentions "machine vision detection" which is a component often used in AI/ML systems, but it doesn't explicitly state that AI or ML algorithms are used for the INR calculation or any other function beyond basic image processing for detection. The description of the performance studies and key metrics does not provide further evidence of AI/ML use.
No.
The device measures PT/INR for monitoring anticoagulant therapy, but it does not directly provide therapy or treatment.
Yes
The device measures prothrombin time (PT) and International Normalized Ratio (INR) to monitor oral anticoagulant therapy, which is a diagnostic function used to assess a patient's physiological state and guide medical treatment.
No
The device description explicitly states the system is comprised of a portable measuring device (microINR® Meter) and test strips (microINR® Chips), which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is explicitly stated to "measure prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin." This is a diagnostic measurement performed on a biological sample (blood).
- Sample Type: It uses "fresh capillary whole blood from a fingerstick," which is a biological specimen.
- Method: The device performs a "Prothrombin Time (PT) assay carried out in the microINR® Chip based on microfluidic technology with machine vision detection." An assay is a laboratory test to measure the amount of a substance.
- Device Description: The description details the components (meter and chips) and how they work together to perform the test on the blood sample.
- Performance Studies: The document describes performance studies comparing the device's results to other methods (healthcare professional use, laboratory system), which is typical for IVD validation.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.
The microINR System consists of a microINR Meter and microINR Chip and uses fresh capillary whole blood from a fingerstick.
The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.
The microINR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.
For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.
Product codes
GJS
Device Description
The microINR® System is comprised of a portable measuring device (microINR® Meter) and test strips (microINR® Chips) in which the capillary blood sample flows through capillary action.
The microINR® Chip contains a reagent in dried form which consists of thromboplastin, and contains two symmetrical regions, the measuring channel and a control channel. The microINR® Meter measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay carried out in the microINR® Chip based on microfluidic technology with machine vision detection.
The microINR® System has a multi-level On-board Quality Control. Multiple key functions and elements of the system are checked and if deviations are detected, error messages are displayed and test results are not reported.
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 old or older
Intended User / Care Setting
patient self-testing use as well as for healthcare professionals at Point of Care settings.
For Self-testing use: The System is intended for properly trained users under specific prescription of a physician.
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
The use of the microINR® System by self-testers was validated by an external user study that was conducted as the System is intended to be used. Following training, the patients self-tested in the home setting for up to 2 weeks. The patients had 2 scheduled visits to their study site to collect patient vs. healthcare professional data in terms of accuracy and repeatability. The study results successfully demonstrated that trained patient self-testers can obtain results that are equivalent to those obtained by healthcare professionals. This study also demonstrated that self-testers are satisfied with the user-friendliness of the microINR® System.
Accuracy: A Method Comparison Study was conducted at four clinical sites comparing the INR test results obtained by patient self-testers (PST) to those obtained by healthcare professionals (HCP) using the microINR® System in two visits to the sites (N = 225, Slope = 1.00, Intercept = 0.00 and Correlation Coefficient = 0.932).
Precision: The microINR® System precision was determined based on duplicate measurements performed at four clinical sites by patient self-testers in the second visit to the site. (N = 110, Mean = 2.61, SD = 0.13, CV (%) = 5.0)
Key Metrics
Accuracy: Slope = 1.00, Intercept = 0.00 and Correlation Coefficient = 0.932 (PST vs HCP)
Accuracy: Slope = 0.95, Intercept = 0.12, Correlation Coefficient r = 0.922 (PST vs Laboratory System)
Precision: SD = 0.13, CV (%) = 5.0
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 18, 2020
iLine Microsystems S.L. c/o Marcia Zucker Consultant ZIVD LLC 62 Pollard Road Plaistow, New Hampshire 03865
Re: K201185
Trade/Device Name: microINR System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: April 27, 2020 Received: May 1, 2020
Dear Marcia Zucker:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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/medicaldevices/device-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,
for Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201185
Device Name microINR System
Indications for Use (Describe)
The microlNR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.
The microINR System consists of a microINR Meter and microINR Chip and uses fresh capillary whole blood from a fingerstick.
The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.
The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.
For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is a logo for "iLine microsystems". The logo is set against a blue background with rounded corners. The word "iLine" is prominently displayed in a stylized font, with the "i" in lowercase and the rest of the word in uppercase. The word "microsystems" is written in a smaller font size below "iLine". A circled "R" trademark symbol is located to the right of the "e" in "iLine".
510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. SUBMITTER INFORMATION
| Owner | iLine Microsystems, S.L.
Paseo Mikeletegi, 69
20009 Donostia, Guipúzcoa
Spain |
|-----------------------|------------------------------------------------------------------------------------------------------------|
| Contact | Miren Itsaso Hormaeche
ihormaeche@ilinemicrosystems.com
Tel. +34 943 005 651
Fax: +34 943 008 737 |
| Date Summary Prepared | December 10, 2020 |
2. DEVICE INFORMATION
| Proprietary Name | microINR® System |
|---|---|
| Common Name | Prothrombin time test |
| Panel | Hematology |
Regulatory Information:
| Classification | ||||
|---|---|---|---|---|
| Device | Regulation Section | Device Class | Product Code | Test |
| microINR® System | 21 CFR 864.7750 | II | GJS | Prothrombin time test |
510k Premarket Notification
4
3. SUBSTANTIAL EQUIVALENCE INFORMATION:
| Element | Predicate Device |
|---|---|
| Predicate Device Name | microINR® System |
| Common Name | Prothrombin time test |
| 510 (k) Number | K180780 |
| Manufacturer | iLine Microsystems |
4. DEVICE DESCRIPTION:
The microINR® System is comprised of a portable measuring device (microINR® Meter) and test strips (microINR® Chips) in which the capillary blood sample flows through capillary action.
The microINR® Chip contains a reagent in dried form which consists of thromboplastin, and contains two symmetrical regions, the measuring channel and a control channel. The microINR® Meter measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay carried out in the microINR® Chip based on microfluidic technology with machine vision detection.
The microINR® System has a multi-level On-board Quality Control. Multiple key functions and elements of the system are checked and if deviations are detected, error messages are displayed and test results are not reported.
5. INDICATIONS FOR USE/INTENDED USE:
The microINR® System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.
The microINR® System consists of a microINR® Meter and microINR® Chip and uses fresh capillary whole blood from a fingerstick.
The microINR® System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.
5
Image /page/5/Picture/1 description: The image is a logo for iLine microsystems. The logo is set against a blue background. The word "iLine" is written in white, with the "i" in lowercase and the rest of the word in uppercase. The word "microsystems" is written in a smaller font size below "iLine".
The microINR® System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR® System.
For Self-testing use: The System is intended for properly trained users under specific prescription of a physician.
Caution: The microINR® System is not intended for use in patients who are transitioning from heparin treatment to VKA therapy. The microINR® System is not intended to be used for screening purposes.
6. SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS (PREDICATE):
The following table compares the microINR® System with its predicate device, microINR® System for professional use (K180780).
| Similarities | ||
|---|---|---|
| Item | microINR® System | microINR® System (K180780) |
| Intended | ||
| Use/Indications for | ||
| Use | ||
| (Differences | ||
| highlighted in italic) | The microINR® System | |
| measures prothrombin time (PT) | ||
| expressed in International | ||
| Normalized Ratio (INR), for | ||
| monitoring oral anticoagulant | ||
| therapy with warfarin. | ||
| The microINR® System is | ||
| intended for patient self-testing | ||
| use as well as for healthcare | ||
| professionals at Point of Care | ||
| settings. | ||
| The microINR® System is | ||
| intended for use in patients 18 | ||
| years old or older. Patients must | ||
| be stable on warfarin medication | ||
| for at least 6 weeks before | ||
| starting to use the microINR® | ||
| System. | The microINR® System | |
| (consisting of the microINR® | ||
| Meter and the microINR® Chip) | ||
| is intended for multiple-patient | ||
| use by professional healthcare | ||
| providers for the determination | ||
| of International Normalized Ratio | ||
| (INR), to monitor Oral | ||
| Anticoagulation Therapy (OAT) | ||
| with warfarin. The microINR® | ||
| system uses fresh capillary whole | ||
| blood. The microINR® System is | ||
| intended for in vitro diagnostic | ||
| use at the point-of-care. | ||
| The microINR® System is | ||
| intended for use in patients 18 | ||
| years of age and older. Patients | ||
| Similarities | ||
| Item | microINR® System | microINR® System (K180780) |
| For Self-testing use: The System | ||
| is intended for properly trained | ||
| users under specific prescription | ||
| of a physician. | ||
| Caution: The microINR® System | ||
| is not intended for use in patients | ||
| who are transitioning from | ||
| heparin treatment to VKA | ||
| therapy. The microINR System® | ||
| is not intended to be used for | ||
| screening purposes. | must be stabilized (≥6 weeks) on | |
| warfarin. | ||
| Caution: The microINR® System | ||
| is not intended for use in patients | ||
| who are transitioning from | ||
| heparin treatment to warfarin | ||
| therapy. The microINR® System | ||
| is not intended to be used for | ||
| screening purposes. | ||
| Sample type | Capillary whole blood. | Same. |
| Operating | ||
| Principle/Technology | Microfluidic technology with | |
| machine vision detection. | Same. | |
| Operating | ||
| Temperature | 15 – 35°C (59 – 95°F). | Same. |
| Test Strip Reagent | Human recombinant | |
| thromboplastin. | Same. | |
| Measuring Range | 0.8 – 4.5 INR. | 0.8 – 6.0 INR. |
| Calibration | ||
| traceability | Each lot of test strips is calibrated | |
| to a reference lot traceable to the | ||
| WHO International Reference | ||
| Preparation. | Same. | |
| Reference Range | INR: 0.8 to 1.2. | Same. |
| Calibration | Automatic, encoded on | |
| disposable, no end user input | ||
| possible. | Same. | |
| Test Strip Stability | 15 months. | Same. |
| Test Strip Use Time | 6 hours. | |
| (Limited to 15 minutes in IFU). | 6 hours. | |
| Similarities | ||
| Item | microINR® System | microINR® System (K180780) |
| Sample Volume | A minimum of 3 μL. | Same. |
| On-Board Quality | ||
| Control | Multi-level on-board quality | |
| controls. | Same. | |
| Memory Capacity | 199 (results with time and date). | Same. |
| Hematocrit Range | Hematocrit ranges between 25- | |
| 55% do not significantly affect | ||
| test results. | Same. | |
| Hemoglobin | No significant effect up to 1000 | |
| mg/dL. | Same. | |
| Bilirubin | Bilirubin up to 40 mg/dL has no | |
| significant effect on test results. | Same. | |
| Triglyceride | Lipemic samples containing up to | |
| 3270 mg/dL of triglycerides have | ||
| no significant effect on test | ||
| results. | Same. | |
| Heparin | Use excluded in IFU. | Same. |
| Low Molecular | ||
| Weight Heparin | Use excluded in IFU. | Same. |
| Expiration data lock | ||
| out | Automatic, encoded on | |
| disposable, no end user input | ||
| possible. | Same. |
6
Image /page/6/Picture/0 description: The image is a logo for iLine microsystems. The logo is set against a blue background. The word "iLine" is written in white, with the "i" in lowercase and the rest of the word in uppercase. The word "microsystems" is written in a smaller font size below "iLine" and is also in white. A circled "R" trademark symbol is located to the upper right of the word "iLine".
7
Image /page/7/Picture/0 description: The image is a logo for iLine microsystems. The logo is set against a blue background. The word "iLine" is written in a stylized, sans-serif font, with the "i" in lowercase and the "L" in uppercase. The word "microsystems" is written in a smaller, sans-serif font below "iLine."
8
Image /page/8/Picture/0 description: The image shows the logo for iLine microsystems. The logo is set against a blue background with rounded corners. The word "iLine" is written in white, with a registered trademark symbol to the upper right. Below "iLine" is the word "microsystems" in a smaller, sans-serif font, also in white.
510(k) SUMMARY
| Differences | ||
|---|---|---|
| Item | microINR® System | microINR® System (K180780) |
| Intended | ||
| Use/Indications for | ||
| Use | As indicated in the Similarities | |
| Table above. | ||
| Limitations of POC | ||
| settings | The microINR® System is | |
| intended to be used in Point of | ||
| Care settings such as physicians' | ||
| offices and anticoagulation | ||
| clinics, as well as home settings. | ||
| It is not intended to be used in | ||
| nursing homes, emergency | ||
| rooms or intensive care units. | No limitations. | |
| External Liquid | ||
| Quality Control | Not available. | External optional liquid quality |
| controls. | ||
| EMC testing | IEC 60601-1-2:2014 | |
| (ESD testing 8kV contact and | ||
| 15kV air discharges). | 60601-1-2:2007 | |
| (ESD testing 6kV contact and | ||
| 8kV air discharges). | ||
| SW | Date format: year with 4 digits. | |
| Error message E13 (control for | ||
| chip US vs ROW models). | Date format: year with 2 digits. | |
| No E13 available. |
Additional hardware and software changes have been made due to component obsolescence, to increase the resistance to electrostatic discharges or to resolve minor software anomalies (bugs). None of these modifications affects product performance.
9
Image /page/9/Picture/1 description: The image features the logo for "iline microsystems". The logo is set against a blue rounded rectangle. The word "iline" is prominently displayed in white, with a registered trademark symbol to the upper right. Below "iline", the word "microsystems" is written in a smaller, sans-serif font, also in white.
7. STANDARD/GUIDANCE DOCUMENT REFERENCED:
In addition to the guidances previously submitted, reviewed and cleared under the premarket notification for the microINR® System (K180780), the following guidances have been followed:
- · ANSI/AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for safety and essential performance,
- ANSI/AAMI IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests,
- · IEC 60601-2-37 Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability,
- · IEC 60601-1-11:2010 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment,
- · IEC 62304 Medical Device Software Software Life Cycle Processes,
- Format for Traditional and Abbreviated 510(k)s. Guidance for Industry and Food and Drug Administration Staff,
- · Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff,
- · Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Guidance for Industry and Food and Drug Administration Staff.
8. TEST PRINCIPLE
The microINR® System was previously cleared for professional use under premarket notification K180780. The test principle has not been modified:
The microINR® System is a handheld in vitro diagnostic medical device that uses microfluidic technology with machine vision detection to measure the prothrombin time from a fresh capillary (fingerstick) whole blood sample. The fresh capillary (fingerstick) whole blood sample is applied to the microINR® Chips (test strips) for testing. The microINR® Chip is inserted into the analyzer. Two microcapillary channels in the test strip are filled with the blood sample by capillary action. The microINR® Chip contains a preparation of human recombinant tissue factor, synthetic phospholipids and stabilizers. The microINR® Meter measures the International Normalized Ratio (INR) based on the Prothrombin Time (PT) assay carried out in the microINR® Chip and displays the International Normalized Ratio (INR) on the screen.
10
Image /page/10/Picture/1 description: The image shows a logo for "iline microsystems". The logo is set against a blue rounded rectangle. The word "iline" is written in white, with the "i" in lowercase and the rest of the letters in uppercase. The word "microsystems" is written in a smaller font size below "iline".
9. PERFORMANCE CHARACTERISTICS
The following characteristics have been previously submitted, reviewed and cleared under the premarket notification for the microINR® System (K180780):
- Precision/Repeatability
- . Reproducibility/Intermediate Precision
- Linearity/Assay Reportable Range ●
- Traceability (Calibration)
- microINR® Chips Stability
- Detection Limit (Factor Sensitivity)
- Interfering Substances
- Clinical Method Comparison Study ●
- Expected Values/Reference Range
These characteristics are not impacted by the new user population.
The use of the microINR® System by self-testers was validated by an external user study that was conducted as the System is intended to be used. Following training, the patients self-tested in the home setting for up to 2 weeks. The patients had 2 scheduled visits to their study site to collect patient vs. healthcare professional data in terms of accuracy and repeatability. The study results successfully demonstrated that trained patient self-testers can obtain results that are equivalent to those obtained by healthcare professionals. This study also demonstrated that self-testers are satisfied with the user-friendliness of the microINR® System.
The performance characteristics potentially affected by the new user population (accuracy and precision) were evaluated. The following information has been incorporated into the microINR® Chip instructions for use.
Accuracy
A Method Comparison Study was conducted at four clinical sites comparing the INR test results obtained by patient self-testers (PST) to those obtained by healthcare professionals (HCP) using the microINR® System in two visits to the sites (N = 225, Slope = 1.00, Intercept = 0.00 and Correlation Coefficient = 0.932).
The INR test results obtained at second visit by PST were compared to a laboratory system (ACL TOP 500) reference method (N = 112, Slope = 0.95, Intercept = 0.12, Correlation Coefficient r = 0.922).
The results indicate that microINR® System patient self-testers are able to obtain results as accurate as those obtained by healthcare professionals using the microINR® System.
510k Premarket Notification
11
Image /page/11/Picture/1 description: The image shows the logo for iLine microsystems. The logo is set on a blue rounded rectangle. The word "iline" is in a large white sans-serif font, with a registered trademark symbol next to it. Below "iline" is the word "microsystems" in a smaller white sans-serif font.
Precision
The microINR® System precision was determined based on duplicate measurements performed at four clinical sites by patient self-testers in the second visit to the site. The following results were obtained:
| Paired results | |
|---|---|
| N | 110 |
| Mean | 2.61 |
| SD | 0.13 |
| CV (%) | 5.0 |
10. INSTRUMENT NAME
microINR® Meter.
11. SYSTEM DESCRIPTION
The microINR® System was previously cleared for professional use under premarket notification K180780. The following characteristics remain the same:
11.1. Modes of Operation
The microINR® System is a closed system, which is intended to be used exclusively with the microINR® Chips manufactured by iLine Microsystems, S.L.
11.2. Software
The user interface of the microINR® Meter guides the user through the test procedure step by step. The user only needs to insert the Chip and apply a blood sample. The microINR® System measures International Normalized Ratio (INR) based on a Prothrombin Time (PT) assay and displays the result. After the test is completed, the meter automatically saves the test result.
11.3. Specimen Sampling and Handling
The microINR® Chip is intended for single-use only. Once the Chip is inserted into the device, a drop of fresh capillary whole blood sample collected by fingerstick is manually applied to the Chip and analyzed by the microINR® Meter.
12
Image /page/12/Picture/1 description: The image shows the logo for iLine microsystems. The logo is set against a blue background. The word "iLine" is written in a sans-serif font, with the "i" in lowercase and the rest of the word in uppercase. A registered trademark symbol is placed to the upper right of the word "iLine". Below "iLine" is the word "microsystems" in a smaller, sans-serif font.
11.4. Calibration
Each lot of microINR® Chips is calibrated to a reference lot of human recombinant thromboplastin traced to International Reference Thromboplastin of the World Health Organization.
These calibration parameters (International Sensitivity Index (ISI) and Mean Normal Prothrombin Time (MNPT)) are encoded in the printed Datamatrix of each microINR® Chip along with information related to expiration date. Therefore, every test is automatically and individually calibrated eliminating any risk of human error.
11.5. Quality Control
The microINR® System provides both Meter´s functional Quality Controls and On-Board Quality Controls.
First, Meter performance is automatically checked for electronic components, correct power battery level and environmental temperature conditions.
Then, On-Board Controls provide a quality control check for each individual microINR® Chip used with the microINR® Meter. microINR® System has been designed to detect errors prior to and during the test in order to prevent inaccurate INR results through a multi-level strategy.
12. CONCLUSION
The microINR® System was previously cleared for professional use under premarket notification K180780.
This premarket notification is being submitted to obtain clearance for microINR System Home Use (i.e. patient self-testing), and therefore CLIA waiver for the professional use in Point Of Care settings. The performance characteristics that are affected by the new user population were evaluated and revealed that trained patient self-testers can obtain results on the microINR® System equivalent to those obtained by healthcare professionals.