Cleared Traditional

K062203 - TINA-QUANT D-DIMER TEST SYSTEM

K062203 is the FDA 510(k) clearance for TINA-QUANT D-DIMER TEST SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Hematology device (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

Submission Details

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.

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 13
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K062203.
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
ABBOTT IMX(TM) D-DIMER
K893961 · Abbott Laboratories · Aug 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · Abbott Laboratories · Mar 1989