# K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device

- Pathway: 510(k) (Traditional)
- Applicant: Coagusense, Inc.
- Decided: Feb 21, 2019 after 92 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962571 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050243: Immedia Prothrombin Time System, Farallon Medial, Inc. (2005) Summary page 4.
- K093243: Coagusense Self-Test Prothrombin Time/Inr Monitoring System, Coagusense, Inc. (2010) Summary page 4.

## Most influential descendants
- K212779: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (2022), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1583-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System (Self-Test) is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood. It 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 device is not intended to be used for screening purposes.

Source page: https://510kreport.com/device/K183255
Methodology: https://510kreport.com/methodology