# K253188: CoaguChek XS Plus System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Oct 24, 2025 after 28 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010599 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180684: CoaguChek XS Plus System, Roche Diagnostics (2018) Summary page 6.

## 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/K253188
Methodology: https://510kreport.com/methodology