Cleared Traditional

K002706 - ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON...

Also marketed or referenced as:
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI

K002706 is the FDA 510(k) clearance for ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON... by Roche Diagnostics Corp.. It is a Class 2 Hematology device (product code DAP) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K002706 · Roche Diagnostics Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 2001
Decision
198d
Days
Class 2
Risk

K002706 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 16, 2001 after a review of 198 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 K002706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2000
Decision Date March 16, 2001
Days to Decision 198 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
85d slower than avg
Panel avg: 113d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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 - DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

All 38
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K002706.
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549 · Sigma Diagnostics, Inc. · Dec 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
K013544 · Sigma Diagnostics, Inc. · Nov 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · Sigma Diagnostics, Inc. · Nov 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · Sigma Diagnostics, Inc. · Mar 2001
MDA D-DIMER
K000492 · Organon Teknika Corp. · Jun 2000
ADVANCED D-DIMER
K992957 · Dade Behring, Inc. · Jan 2000