Cleared Traditional

K040882 - VIDAS D-DIMER EXCLUSION ASSAY

K040882 is the FDA 510(k) clearance for VIDAS D-DIMER EXCLUSION ASSAY by bioMerieux, Inc.. It is a Class 2 Hematology device (product code DAP) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K040882 · bioMerieux, Inc. · Hematology device
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Jun 2004
Decision
66d
Days
Class 2
Risk

K040882 is an FDA 510(k) clearance for the VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number K040882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2004
Decision Date June 10, 2004
Days to Decision 66 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
47d faster than avg
Panel avg: 113d · This submission: 66d
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 43
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K040882.
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
K033491 · Roche Diagnostics Corp. · Sep 2004
ADVANCED D-DIMER ASSAY
K041438 · Dade Behring, Inc. · Aug 2004
TRIAGE PROFILER S.O.B. PANEL
K040437 · Biosite Incorporated · Jun 2004
QUANTEX D-DIMER
K032419 · Instrumentation Laboratory CO · Oct 2003
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
K030328 · bioMerieux, Inc. · Sep 2003
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090
K030687 · Kamiya Biomedical Co. · Jun 2003