# K180780: microINR System

- Pathway: 510(k) (Traditional)
- Applicant: Iline Microsystems, S.L.
- Decided: Jan 25, 2019 after 305 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: 3 generations back to K010599 (2001). 3 ancestors in all.
4 later devices descend from it; 3 cite 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)
- K060978: Coaguchek XS System, Roche Diagnostics (2006) Summary page 5.

## Most influential descendants
- K201185: microINR System (2020), 3 descendants of its own
- K231711: microINR System (2023), 2 descendants of its own
- K243543: microINR System (2025), 1 descendant of its own
- K251564: microINR System (2025), 0 descendants of its own

## Indications for use
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) 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. The microINR chips are only intended to be used with the microINR meter. microINR Control Level A / microINR Control Level B: The microINR Control is intended for quality control performed on the microINR Meter when used with the disposable microINR Chips. iLine Microsystems has available two microINR Control Levels (A and B) to perform quality control checks in the therapeutic range on the microINR System. The microINR Control is intended for professional use only.

Source page: https://510kreport.com/device/K180780
Methodology: https://510kreport.com/methodology