microINR System

K231711 · Iline Microsystems, S.L. · GJS · Jul 11, 2023 · Hematology

Device Facts

• Record ID: K231711
• Device Name: microINR System
• Applicant: Iline Microsystems, S.L.
• Product Code: GJS · Hematology
• Decision Date: Jul 11, 2023
• Decision: SESE
• Submission Type: Special
• 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 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

microINR System measures PT/INR in fresh capillary whole blood; utilizes microINR Chip for analysis; provides quantitative INR results. Modification adds optional Bluetooth connectivity to meter (microINR Link Meter) for data transmission; no changes to microINR Chip or fundamental scientific technology. Used by patients for self-testing or healthcare professionals at point-of-care. Output displayed on meter; assists in monitoring oral anticoagulation therapy; enables patient management of vitamin K antagonist therapy.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of the Bluetooth connectivity modification.

Technological Characteristics

System consists of microINR Meter and microINR Chip. Modification adds Bluetooth Low Energy (BLE) connectivity for data transfer. Fundamental measurement technology remains unchanged from predicate. Device is a point-of-care diagnostic system.

Indications for Use

Indicated for patients on vitamin K antagonist oral anticoagulation therapy requiring PT/INR monitoring. Intended for both patient self-testing and professional point-of-care use.

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

• microINR System (K201185)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K231711

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 Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device (K201185). (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for adding Bluetooth connectivity (optional) to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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the microINR Meter (microINR Link Meter). No changes have been made to the microINR Chip.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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