# K212779: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

- Pathway: 510(k) (Special)
- Applicant: Coagusense, Inc.
- Decided: Oct 5, 2022 after 399 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: 4 generations back to K962571 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
3 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device, Coagusense, Inc. (2019) Summary page 4.

## Indications for use
The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in INR units. It uses fresh capillary whole blood. The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is not intended to be used for screening purposes. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is intended to be used by a single person and should not be shared.

Source page: https://510kreport.com/device/K212779
Methodology: https://510kreport.com/methodology