# K063823: Coaguchek XS PT Controls

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 29, 2007 after 34 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K020863: Carto XP and Qwikmap EP Navigation System, Biosense Webster, Inc. (2003). Our reading of the summary gave K020863, FDA’s number for Carto XP and Qwikmap EP Navigation System (Biosense Webster, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CoaguChek PT S System Controls”. Kept off the family tree. Summary page 1.

## Indications for use
CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips.

Source page: https://510kreport.com/device/K063823
Methodology: https://510kreport.com/methodology