Cleared Traditional

K062203 - TINA-QUANT D-DIMER TEST SYSTEM

K062203 is an FDA 510(k) clearance for TINA-QUANT D-DIMER TEST SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Hematology device with product code GHH cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K062203 · Roche Diagnostics Corp. · Hematology device
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Mar 2007
Decision
225d
Days
Class 2
Risk

K062203 is an FDA 510(k) clearance for the TINA-QUANT D-DIMER TEST SYSTEM. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 14, 2007 after a review of 225 days - an extended review cycle.

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: 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K062203

510(k) Number K062203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date March 14, 2007
Days to Decision 225 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
112d slower than avg
Panel avg: 113d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GHH Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K062203.
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
K112120 · Diazyme Laboratories · Jan 2013
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
OPUS D-DIMER
K972316 · Behring Diagnostics, Inc. · Sep 1997