Cleared Traditional

MDA D-DIMER (K974776) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974776 · Organon Teknika Corp. · Hematology device
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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

Submission Details

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.

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 30
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
IL TEST D-DIMER
K972696 · Instrumentation Laboratory CO · Nov 1997
AURATEK FDP
K943787 · Organon Teknika Corp. · Sep 1994
FIBRINOSTIKA TDP MICROELISA SYSTEM
K915698 · Organon Teknika Corp. · Aug 1992