Cleared Traditional

K033491 - ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY

Also marketed or referenced as:
ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS

K033491 is an FDA 510(k) clearance for ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K033491 · Roche Diagnostics Corp. · Hematology device
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Sep 2004
Decision
302d
Days
Class 2
Risk

K033491 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY. 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 September 1, 2004 after a review of 302 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K033491

510(k) Number K033491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2003
Decision Date September 01, 2004
Days to Decision 302 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
189d slower than avg
Panel avg: 113d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAP Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K033491.
HEMOSIL D-DIMER HS
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K050278 · Instrumentation Laboratory CO · Mar 2005
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
K042723 · Biosite Incorporated · Dec 2004
ADVANCED D-DIMER ASSAY
K041438 · Dade Behring, Inc. · Aug 2004
TRIAGE PROFILER S.O.B. PANEL
K040437 · Biosite Incorporated · Jun 2004
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
K040882 · bioMerieux, Inc. · Jun 2004