# K092940: Coaguchek XS Plus PST System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 5, 2010 after 162 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: 4 generations back to K010599 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071041: Coaguchek XS Plus System, Roche Diagnostics (2007) Summary page 1.

## Indications for use
The CoaguChek XS Plus System measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

Source page: https://510kreport.com/device/K092940
Methodology: https://510kreport.com/methodology