Cleared Traditional

K000492 - MDA D-DIMER

K000492 is an FDA 510(k) clearance for MDA D-DIMER, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K000492 · Organon Teknika Corp. · Hematology device
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Jun 2000
Decision
113d
Days
Class 2
Risk

K000492 is an FDA 510(k) clearance for the MDA D-DIMER. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on June 7, 2000 after a review of 113 days - within the typical 510(k) review window.

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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K000492

510(k) Number K000492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2000
Decision Date June 07, 2000
Days to Decision 113 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
At panel average
Panel avg: 113d · This submission: 113d
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 44
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K000492.
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · Kamiya Biomedical Co. · May 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706 · Roche Diagnostics Corp. · Mar 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · Sigma Diagnostics, Inc. · Mar 2001
ADVANCED D-DIMER
K992957 · Dade Behring, Inc. · Jan 2000
MDA D-DIMER
K974776 · Organon Teknika Corp. · Apr 1998
VIDAS D-DIMER (DD) ASSAY
K973819 · Biomerieux Vitek, Inc. · Mar 1998