# K020831: PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 24, 2002 after 224 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: 1 generation back to K010599 (2001). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
4 of 20 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.

## Most influential descendants
- K060978: Coaguchek XS System (2006), 16 descendants of its own
- K071041: Coaguchek XS Plus System (2007), 6 descendants of its own
- K180780: microINR System (2019), 4 descendants of its own
- K201185: microINR System (2020), 3 descendants of its own
- K231711: microINR System (2023), 2 descendants of its own

## Indications for use
The Coaguchek S System is intended for quantitative Prothornbin Time (PT)testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional health care providers.

Source page: https://510kreport.com/device/K020831
Methodology: https://510kreport.com/methodology