Cleared Traditional

K071265 - SMARTCHECK INR SYSTEM

K071265 is the FDA 510(k) clearance for SMARTCHECK INR SYSTEM by Inverness Medical Innovations, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K071265 · Inverness Medical Innovations, Inc. · Hematology device
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Nov 2007
Decision
207d
Days
Class 2
Risk

K071265 is an FDA 510(k) clearance for the SMARTCHECK INR SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Inverness Medical Innovations, Inc. (Waltham, US). The FDA issued a Cleared decision on November 30, 2007 after a review of 207 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inverness Medical Innovations, Inc. devices

Submission Details

510(k) Number K071265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2007
Decision Date November 30, 2007
Days to Decision 207 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 113d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 117
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K071265.
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