Cleared Traditional

K072288 - PATHFAST D-DIMER

K072288 is the FDA 510(k) clearance for PATHFAST D-DIMER by Mitsubishi Kagaku Iatron. It is a Class 2 Hematology device (product code GHH) cleared through the Traditional 510(k) pathway after a 629-day FDA review.

K072288 · Mitsubishi Kagaku Iatron · Hematology device
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May 2009
Decision
629d
Days
Class 2
Risk

K072288 is an FDA 510(k) clearance for the PATHFAST D-DIMER. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Mitsubishi Kagaku Iatron (Seattle, US). The FDA issued a Cleared decision on May 6, 2009 after a review of 629 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Mitsubishi Kagaku Iatron devices

Submission Details

510(k) Number K072288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2007
Decision Date May 06, 2009
Days to Decision 629 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
516d slower than avg
Panel avg: 113d · This submission: 629d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHH Fibrin Split Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
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 - GHH Fibrin Split Products

All 19
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K072288.
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
K112120 · Diazyme Laboratories · Jan 2013
TINA-QUANT D-DIMER TEST SYSTEM
K062203 · Roche Diagnostics Corp. · Mar 2007
TRIAGE D-DIMER TEST, MODEL 98100
K042890 · Biosite Incorporated · Nov 2004
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K030740 · Roche Diagnostics Corp. · Apr 2003
MDA D-DIMER
K021877 · bioMerieux, Inc. · Aug 2002
TINA-QUANT D-DIMER TEST SYSTEM
K011143 · Roche Diagnostics Corp. · May 2001