# K050243: Immedia Prothrombin Time System

- Pathway: 510(k) (Traditional)
- Applicant: Farallon Medial, Inc.
- Decided: Jun 6, 2005 after 124 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roche CoaguChek S: named in the summary without a submission number

## 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

## Indications for use
The Imrnmedia System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood. It is intended for use by health care professional at the point of care to monitor patients who are on warfarin-type (coumarin) anticoagulation therapy. The device is not intended to be used for screening purposes.

Source page: https://510kreport.com/device/K050243
Methodology: https://510kreport.com/methodology