# K180693: CoaguChek XS Pro System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Apr 19, 2018 after 34 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)
- K093460: Coaguchek XS Pro System, Roche Diagnostics (2010) Summary page 4.

## Indications for use
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).

Source page: https://510kreport.com/device/K180693
Methodology: https://510kreport.com/methodology