Cleared Traditional

K030328 - VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442

K030328 is an FDA 510(k) clearance for VIDAS D-DIMER NEW (DD2) ASSAY, manufactured by bioMerieux, Inc.. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K030328 · bioMerieux, Inc. · Hematology device
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Sep 2003
Decision
214d
Days
Class 2
Risk

K030328 is an FDA 510(k) clearance for the VIDAS D-DIMER NEW (DD2) 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 September 2, 2003 after a review of 214 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 bioMerieux, Inc. devices

FDA 510(k) Submission Details - K030328

510(k) Number K030328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2003
Decision Date September 02, 2003
Days to Decision 214 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
101d slower than avg
Panel avg: 113d · This submission: 214d
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 50
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K030328.
TRIAGE PROFILER S.O.B. PANEL
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