# K021190: PT-S Test Strips for the Coaguchek System, Model# 2032422

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 25, 2002 after 193 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010599 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010599: Protime Microcoagulation System / Protime 3 Cuvette, International Technidyne Corp. (2001) Summary page 3.

## Recalls of this device
- Mar 28, 2005 · Not classified · Z-0098-06: Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

## Indications for use
The CoaguChek System is intended for quantitative Prothrombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional healthcare provides.

Source page: https://510kreport.com/device/K021190
Methodology: https://510kreport.com/methodology