# K062925: Coaguchek XS System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 29, 2007 after 123 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010599 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060978: Coaguchek XS System, Roche Diagnostics (2006) Summary page 1.

## Most influential descendants
- K170960: CoaguChek Vantus System (2017), 0 descendants of its own

## Recalls of this device
- Dec 2, 2020 · Class II · Z-0804-2021: Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
- May 16, 2013 · Class II · Z-1581-2013: Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 messag
- Jul 22, 2009 · Not classified · Z-2003-2009: The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
- May 13, 2009 · Not classified · Z-1594-2009: The lancet cap may be missing, which could result in an unintended lancet stick to the user.

## Indications for use
The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin® or warfarin. The CoaguChek XS System uses blood from a finger stick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor. Users should be stabilized on anticoagulation medications such as Coumadin® or warfarin prior to self-testing with the CoaguChek XS System.

Source page: https://510kreport.com/device/K062925
Methodology: https://510kreport.com/methodology