Cleared Traditional

K030328 - VIDAS D-DIMER NEW (DD2) ASSAY

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

K030328 · bioMerieux, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 K030328.
TRIAGE PROFILER S.O.B. PANEL
K040437 · Biosite Incorporated · Jun 2004
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
K040882 · bioMerieux, Inc. · Jun 2004
QUANTEX D-DIMER
K032419 · Instrumentation Laboratory CO · Oct 2003
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090
K030687 · Kamiya Biomedical Co. · Jun 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
K022976 · Dade Behring, Inc. · Jan 2003
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
K022977 · Dade Behring, Inc. · Nov 2002