# K071041: Coaguchek XS Plus System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: May 11, 2007 after 29 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 3 (1 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.
6 later devices descend from it; 4 cite it directly.
3 of 10 devices in its family (counting itself) have 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
- K180684: CoaguChek XS Plus System (2018), 1 descendant of its own
- K093460: Coaguchek XS Pro System (2010), 1 descendant of its own
- K253188: CoaguChek XS Plus System (2025), 0 descendants of its own
- K220282: i-STAT PTplus Cartridge with the i-STAT 1 System (2023), 0 descendants of its own
- K180693: CoaguChek XS Pro System (2018), 0 descendants of its own

## Recalls of this device
- Sep 13, 2018 · Class I · Z-0360-2019: Abnormally high INR test results with the affected CoaguChek test strips
- May 16, 2013 · Class II · Z-1583-2013: 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-2004-2009: The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.

## Indications for use
The CoaguChek XS Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

Source page: https://510kreport.com/device/K071041
Methodology: https://510kreport.com/methodology