# K170960: CoaguChek Vantus System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Dec 25, 2017 after 269 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.
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)
- K062925: Coaguchek XS System, Roche Diagnostics Corp. (2007) Summary page 4.

## 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® Vantus System measures an INR (International Normalized Ratio) based on a prothrombin time (PT) response to monitor the effect of a therapy with vitamin K antagonists by using the CoaguChek XS PT test strips. The CoaguChek Vantus System uses fresh capillary whole blood from a finger stick. The system is intended for properly selected and suitable trained users on the prescription of the treating doctor. Users should be stabilized on anticoagulation with vitamin K antagonists for at least 6 weeks prior to single patient self-testing with the CoaguChek Vantus System. The CoaguChek Vantus System is intended for single patient self-testing only for adults, age 22 years and older.

Source page: https://510kreport.com/device/K170960
Methodology: https://510kreport.com/methodology