# K093243: Coagusense Self-Test Prothrombin Time/Inr Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Coagusense, Inc.
- Decided: Apr 7, 2010 after 174 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: 2 generations back to K962571 (1997). 6 ancestors in all.
2 later devices descend 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 1.
- K021923: Inratio Self-Test, Hemosense, Inc. (2002) Summary page 1.
- K072727: Inratio 2 PT Monitoring System, Hemosense, Inc. (2007) Summary page 1.
- K030845: Coaguchek PT.S Test for Prothrombin Time Self-Testing, Roche Diagnostics Corp. (2003) Summary page 1.

## Most influential descendants
- K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (2019), 1 descendant of its own
- 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 CoaguSense Self-Test PT Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and international normalized ratio (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 doctor. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing with the CoaguSense Self-Test PT Monitoring System. It is not intended to be used for screening purposes.

Source page: https://510kreport.com/device/K093243
Methodology: https://510kreport.com/methodology