# K243543: microINR System

- Pathway: 510(k) (Traditional)
- Applicant: Iline Microsystems, S.L.
- Decided: Feb 27, 2025 after 104 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010599 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180780: microINR System, Iline Microsystems, S.L. (2019) Summary page 6.
- K201185: microINR System, Iline Microsystems, S.L. (2020) Summary page 6.
- K231711: microINR System, Iline Microsystems, S.L. (2023) Summary page 6.

## Most influential descendants
- K251564: microINR System (2025), 0 descendants of its own

## 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 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.

Source page: https://510kreport.com/device/K243543
Methodology: https://510kreport.com/methodology