# K060978: Coaguchek XS System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 11, 2006 after 123 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010599 (2001). 2 ancestors in all.
16 later devices descend from it; 5 cite it directly.
4 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020831: PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404, Roche Diagnostics Corp. (2002) Summary page 1.

## Most influential descendants
- K071041: Coaguchek XS Plus System (2007), 6 descendants of its own
- K180780: microINR System (2019), 4 descendants of its own
- K201185: microINR System (2020), 3 descendants of its own
- K231711: microINR System (2023), 2 descendants of its own
- K243543: microINR System (2025), 1 descendant of its own

## Recalls of this device
- Dec 2, 2020 · Class II · Z-0803-2021: 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-1584-2013: 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-2002-2009: The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.

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

Source page: https://510kreport.com/device/K060978
Methodology: https://510kreport.com/methodology