Cleared Traditional

K972696 - IL TEST D-DIMER

K972696 is the FDA 510(k) clearance for IL TEST D-DIMER by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code DAP) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K972696 · Instrumentation Laboratory CO · Hematology device
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Nov 1997
Decision
109d
Days
Class 2
Risk

K972696 is an FDA 510(k) clearance for the IL TEST D-DIMER. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 4, 1997 after a review of 109 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K972696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1997
Decision Date November 04, 1997
Days to Decision 109 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
4d faster than avg
Panel avg: 113d · This submission: 109d
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 38
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K972696.
MDA D-DIMER
K000492 · Organon Teknika Corp. · Jun 2000
ADVANCED D-DIMER
K992957 · Dade Behring, Inc. · Jan 2000
MDA D-DIMER
K974776 · Organon Teknika Corp. · Apr 1998
STA-LIATEST D-DI TEST KIT
K964728 · American Bioproducts Co. · Jun 1997
STA D-DI CALIBRATOR KIT
K964718 · American Bioproducts Co. · May 1997
AURATEK FDP
K943787 · Organon Teknika Corp. · Sep 1994