# K071265: Smartcheck Inr System

- Pathway: 510(k) (Traditional)
- Applicant: Inverness Medical Innovations, Inc.
- Decided: Nov 30, 2007 after 207 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
Longest line of descent: 2 generations back to K930454 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020831: PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404, Roche Diagnostics Corp. (2002) Summary page 1.
- K994349: Coaguchek S System, Model 2138280, Roche Diagnostics Corp. (2000) Summary page 1.

## Indications for use
The SmartCheck INRTM System is intended for quantitative testing of Prothrombin Time in capillary blood. Results are given in International Normalized Ratio (INR) units. The SmartCheck INR System is indicated for use by trained medical professionals in a point of care setting for monitoring the INR of patients on oral anticoagulant therapy.

Source page: https://510kreport.com/device/K071265
Methodology: https://510kreport.com/methodology