# K180684: CoaguChek XS Plus System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Apr 19, 2018 after 35 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010599 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071041: Coaguchek XS Plus System, Roche Diagnostics (2007) Summary page 4.

## Most influential descendants
- K253188: CoaguChek XS Plus System (2025), 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

## 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/K180684
Methodology: https://510kreport.com/methodology