# K092987: Inratio/INRATIO2 Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jun 11, 2010 after 256 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 7 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020679 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072727: Inratio 2 PT Monitoring System, Hemosense, Inc. (2007) Summary page 1.

## Most influential descendants
- 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-2362-2016: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or near-therapeutic I
- Jul 11, 2016 · Class I · Z-2361-2016: 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-0881-2015: 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-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
- Apr 16, 2014 · Class I · Z-1546-2014: Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR 
- Feb 28, 2011 · Not classified · Z-2661-2011: The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.

## Indications for use
The INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio/INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio/INRatio 2 PT Monitoring system is not intended to be used for screening purposes.

Source page: https://510kreport.com/device/K092987
Methodology: https://510kreport.com/methodology