Cleared Traditional

K974776 - MDA D-DIMER

K974776 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 115-day FDA review.

K974776 · Organon Teknika Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
115d
Days
Class 2
Risk

K974776 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 April 16, 1998 after a review of 115 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 - K974776

510(k) Number K974776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1997
Decision Date April 16, 1998
Days to Decision 115 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
2d slower than avg
Panel avg: 113d · This submission: 115d
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 K974776.
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · Sigma Diagnostics, Inc. · Mar 2001
MDA D-DIMER
K000492 · Organon Teknika Corp. · Jun 2000
ADVANCED D-DIMER
K992957 · Dade Behring, Inc. · Jan 2000
VIDAS D-DIMER (DD) ASSAY
K973819 · Biomerieux Vitek, Inc. · Mar 1998
IL TEST D-DIMER
K972696 · Instrumentation Laboratory CO · Nov 1997
STA-LIATEST D-DI TEST KIT
K964728 · American Bioproducts Co. · Jun 1997