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Smartcheck Inr System

by Inverness Medical Innovations, Inc.

510(k) K071265

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071265 Date30 Nov 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JPA
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Smartcheck Inr System is a multipurpose in vitro coagulation system designed for the quantitative testing of prothrombin time in capillary blood. It provides results in international normalized ratio units to assist in monitoring patients undergoing oral anticoagulant therapy.

This device is intended for use by trained medical professionals in a point of care setting. It has received FDA 510k clearance under the regulation number 864.5425.

Other devices from Inverness Medical Innovations, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Smartcheck INR System?

    The Smartcheck INR System is a multipurpose in vitro coagulation system used to perform quantitative testing of prothrombin time in capillary blood. It is specifically designed to assist medical professionals in monitoring patients who are currently undergoing oral anticoagulant therapy.

  • Who is the intended user for this device?

    This device is intended for use exclusively by trained medical professionals. It is designed for point of care settings where rapid assessment of coagulation status is required for patient management.

  • What is the regulatory status of the Smartcheck INR System?

    The Smartcheck INR System has received FDA 510k clearance under regulation number 864.5425. This indicates that the device has been reviewed and cleared for use in accordance with established regulatory pathways for in vitro coagulation testing systems.