# K093460: Coaguchek XS Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Mar 18, 2010 after 132 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 3 (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 1.

## Most influential descendants
- K180693: CoaguChek XS Pro System (2018), 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
- May 16, 2013 · Class II · Z-1582-2013: Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 messag
- Mar 6, 2013 · Class II · Z-1114-2013: Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barco

## Indications for use
The CoaguChek XS Pro System (CoaguChiek XS Pro meter and CoguChek 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/K093460
Methodology: https://510kreport.com/methodology