# K030845: Coaguchek PT.S Test for Prothrombin Time Self-Testing

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 22, 2003 after 66 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 K962571 (1997). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962571: Coaguchek PST System, Boehringer Mannheim Corp. (1997) Summary page 1.

## Most influential descendants
- K093243: Coagusense Self-Test Prothrombin Time/Inr Monitoring System (2010), 2 descendants of its own
- K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (2019), 1 descendant of its own
- K212779: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (2022), 0 descendants of its own

## 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
For quantitative prothrombin time testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients or their caregivers on the prescription or other order of the treating doctor.

Source page: https://510kreport.com/device/K030845
Methodology: https://510kreport.com/methodology