# K072727: Inratio 2 PT Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Hemosense, Inc.
- Decided: Oct 26, 2007 after 30 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 6 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020679 (2002). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
4 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020679: Inratio, Hemosense, Inc. (2002) Summary page 1.

## Most influential descendants
- K093243: Coagusense Self-Test Prothrombin Time/Inr Monitoring System (2010), 2 descendants of its own
- K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (2019), 1 descendant of its own
- K092987: Inratio/INRATIO2 Test Strips (2010), 1 descendant of its own
- K212779: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (2022), 0 descendants of its own
- K110212: INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test Strip (2012), 0 descendants of its own

## Recalls of this device
- Jul 11, 2016 · Class I · Z-2357-2016: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a t
- Jul 11, 2016 · Class I · Z-2360-2016: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a t
- Dec 5, 2014 · Class I · Z-0880-2015: In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise i
- Dec 5, 2014 · Class I · Z-0882-2015: In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise i
- Oct 11, 2011 · Not classified · Z-0188-2012: Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus.
- Dec 23, 2008 · Not classified · Z-1256-2009: INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.

## Indications for use
The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.

Source page: https://510kreport.com/device/K072727
Methodology: https://510kreport.com/methodology