Cleared Traditional

K071265 - SMARTCHECK INR SYSTEM

K071265 is an FDA 510(k) clearance for SMARTCHECK INR SYSTEM, manufactured by Inverness Medical Innovations, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K071265

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
Combination Product No
PCCP Authorized No
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.

JPA Device Classification - Class 2, Special Controls

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 159
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