microINR System
Device Facts
| Record ID | K243543 |
|---|---|
| Device Name | microINR System |
| Applicant | Iline Microsystems, S.L. |
| Product Code | GJS · Hematology |
| Decision Date | Feb 27, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
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 meter and chips (test strips) 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 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.
Device Story
The microINR System is a point-of-care and self-testing device for monitoring warfarin therapy. It utilizes a meter and disposable test chips to analyze fresh capillary whole blood from a fingerstick. The system measures prothrombin time (PT) and reports results as an International Normalized Ratio (INR). The modified 'Expert' meter adds a touchscreen, barcode scanner, and expanded connectivity (Wi-Fi, Ethernet, Bluetooth) to existing functionality. Healthcare professionals or trained patients operate the device; results are displayed on the screen to inform clinical decisions regarding anticoagulant dosage. The device benefits patients by enabling convenient, accurate INR monitoring, facilitating timely therapeutic adjustments, and reducing the need for frequent laboratory visits.
Clinical Evidence
Method comparison study conducted at one site with 1384 capillary blood samples comparing microINR Expert Meter to predicate. Results: r=0.987, slope=1.001, intercept=0.001. Usability study (n=15) confirmed users successfully performed tasks (testing, ID entry, settings) with a mean usability score of 4.81/5. Software V&V, EMC, and cybersecurity testing met acceptance criteria.
Technological Characteristics
The system uses a meter and disposable test chips for PT/INR measurement. Connectivity includes Wi-Fi, Ethernet, and Bluetooth. Features a touchscreen display and barcode scanner. The device is intended for point-of-care and home use. Software includes configurable settings for patient/operator identification. The core measuring algorithm is identical to the predicate devices.
Indications for Use
Indicated for patients 18+ years old, stable on warfarin for ≥6 weeks, requiring INR monitoring for oral anticoagulant therapy. Contraindicated for patients transitioning from heparin to VKA therapy and not for screening.
Regulatory Classification
Identification
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
Predicate Devices
Related Devices
- K201185 — microINR System · Iline Microsystems, S.L. · Dec 18, 2020
- K231711 — microINR System · Iline Microsystems, S.L. · Jul 11, 2023
- K251564 — microINR System · Iline Microsystems, S.L. · Jul 21, 2025
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
## I Background Information:
A 510(k) Number
K243543
B Applicant
iLine Microsystems S.L.
C Proprietary and Established Names
microINR System
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GJS | Class II | 21 CFR 864.7750
Prothrombin Time Test | HE - Hematology |
## II Submission/Device Overview:
A Purpose for Submission:
Addition of new functionalities to the existing device
B Measurand:
International Normalized Ratio (INR)
C Type of Test:
Microfluidic technology with machine vision detection
## III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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B Indication(s) 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 meter and chips (test strips) 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 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.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
microINR Expert Meter
IV Device/System Characteristics:
A Device Description:
The microINR System is comprised of a portable measuring device (microINR Expert 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 Expert Meter measures 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. The microINR Control contains lyophilized human citrated plasma from healthy donors modified by means of a process to simulate an abnormal coagulation sample and a calcium chloride solution. The lyophilized plasma must be reconstituted with the calcium chloride solution before use.
The changes to the microINR Expert Meter include the incorporation of optional functions such as connectivity functions (Wi-Fi and Ethernet connectivity on top of the Bluetooth connectivity of the microINR Link), as well as other configurable settings (such as the option of including operator and patient identification), a touchscreen, a barcode scanner, a new QC (quality control)
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mode. The modifications have no impact on fundamental scientific technology and its performance.
# B Principle of Operation:
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 Chip (test strip) for testing. The microINR Chip is inserted into the analyzer. Inside the test strip, the applied blood sample is separated into two channels and mixed with the reagents contained in each micro-reactor. The coagulation cascade is triggered instantly after mixing with the reagents (start time of the Prothrombin Time assay). When the blood coagulates its viscosity increases due to fibrin clot formation, which generates a sharp change in blood flow behavior. The Prothrombin Time measures how long it takes to form the fibrin clot after tissue thromboplastin has been added to the sample. 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.
# V Substantial Equivalence Information:
A Predicate Device Name(s): microINR Meter and microINR Link Meter
B Predicate 510(k) Number(s): K180780 and K231711
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K243543 | K231711 | K180780 |
| --- | --- | --- | --- |
| Device Trade Name | microINR System | microINR System | microINR System |
| General Device Characteristic Similarities | | | |
| 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 meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick.The microINR System is intended for patient self-testing | Same | 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 |
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| | 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 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. | | 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 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 | Same |
| Operating Principle /Technology | Microfluidic technology with machine vision detection. | Same | Same |
| Test Strip Reagent | Human recombinant thromboplastin | Same | Same |
| Measuring Range | 0.8 – 6.0 INR for professional use*
0.8 – 4.5 INR for self-testing use.
(* INR visualization up to 4.5. Both uses commercialized under the same reference) | Same | 0.8 – 6.0 INR for professional use
NA for self-testing |
| Calibration traceability | Each lot of test strips is calibrated to a reference lot traceable to the WHO International Reference Preparation. | Same | Same |
| Reference Range | INR: 0.8 to 1.2 | Same | Same |
| Calibration | Automatic, encoded on disposable, no end user input possible | Same | Same |
| Test Strip Stability | 15 months | Same | Same |
| Test Strip Use Time | 6 hours.
(Limited to 15 minutes in IFU) | Same | 6 hours |
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| Sample Volume | A minimum of 3 μL | Same | Same |
| --- | --- | --- | --- |
| On-Board Quality Control | Multi-level on-board quality controls | Same | Same |
| Expiration data lock out | Automatic, encoded on disposable, no end user input possible | Same | Same |
| 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. | Same | No limitations |
| General Device Characteristic Differences | | | |
| External Liquid Quality Control | Yes (optional) | No | Yes |
| USB connectivity | Yes | No | Yes |
| Bluetooth connectivity | Yes (optional) | Yes | No |
| Patient ID | Yes (optional) | No | Yes (optional) |
| Memory Capacity | 2,000 patient results and 500 quality control test results (results with time and date) | 199 (results with time and date) | 199 (results with time and date) |
| Display: Touchable screen | Yes | No | No |
| Barcode scanner | Yes | No | No |
| Wi-Fi connectivity | Yes (optional) | No | No |
| Ethernet connectivity | Yes (optional) | No | No |
| Ethernet adaptor | Yes (optional) (Sold separately) | No | No |
| Operator identification | Yes (optional) | Only time and date | Only time and date |
VI Standards/Guidance Documents Referenced:
ISO 14971:2019 Medical devices - Application of risk management to medical devices.
IEC 62304:2006/AMD1:2015 Medical device software - Software life cycle processes.
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IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
IEC 61010-1:2010/AMD1:2016/COR1:2019 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements.
IEC 60601-1-2:2014/AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
IEC 60601-4-2:2024. Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
1. **Precision/Reproducibility:**
Refer to K180780 and K201185.
2. **Linearity:**
Refer to K180780.
3. **Analytical Specificity/Interference:**
Refer to K180780.
4. **Assay Reportable Range:**
Refer to K180780 and K201185.
5. **Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):**
Refer to K180780.
6. **Detection Limit:**
Refer to K180780.
7. **Assay Cut-Off:**
Not applicable.
### B Comparison Studies:
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1. Method Comparison with Predicate Device:
The method comparison study was performed at one external clinical site, using a total of 1384 patient capillary whole blood samples obtained during their regular anticoagulation follow up. The study was conducted using a total of 8 microINR Meters and 8 microINR Expert meters. Weighted Deming regression analysis was performed to assess the accuracy of the microINR Expert meters against the predicate device microINR Meters. All results met the pre-defined acceptance criteria.
| N | Result Range | Correlation Coefficient (r) | Intercept (95% CI) | Slope (95% CI) |
| --- | --- | --- | --- | --- |
| 1384 | 0.9 – 6.9 | 0.987 | 0.001 (-0.028, 0.028) | 1.001 (0.985, 1.015) |
2. Matrix Comparison:
Refer to K180780.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable
2. Clinical Specificity:
Not applicable
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Usability study
A usability study was conducted to demonstrate that the new functionalities of the microINR Expert System can be used safely and effectively by potential intended users after reading the labeling. Fifteen participants were enrolled in the study and performed the tasks after reading the labeling. All participants were able to successfully perform all the tasks (conduct a test, administrator identification, change meter settings and data consulting). The participants also participated in a questionnaire to survey the usability of the microINR System. On a scale of 1 to 5 where 1 is least favorable and 5 is most favorable, the mean score was 4.81, indicating that microINR Expert Meter system was easy to use.
Additional testing on the modified device was conducted as follows: software verification and validation; testing for radiofrequency, electromagnetic compatibility and electrical safety; cybersecurity analysis and testing. All testing results met the pre-determined acceptance criteria. Based on the testing, the microINR System including the microINR
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Expert Meter performs as intended, with no new questions of safety or effectiveness identified during testing.
The risk analysis of the implemented changes concluded that the microINR System including the microINR Expert Meter has no significant detectable risks compared to the predicate device and all residual risks have been deemed acceptable.
## D Clinical Cut-Off:
Not applicable.
## E Expected Values/Reference Range:
Refer to K180780.
## VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
## IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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