Cleared Special

K172903 - HemosIL D-Dimer HS 500

K172903 is an FDA 510(k) clearance for HemosIL D-Dimer HS 500, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code DAP cleared through the Special 510(k) pathway after a 61-day FDA review.

K172903 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
61d
Days
Class 2
Risk

K172903 is an FDA 510(k) clearance for the HemosIL D-Dimer HS 500. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on November 22, 2017 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172903

510(k) Number K172903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2017
Decision Date November 22, 2017
Days to Decision 61 days
Submission Type Special
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
52d faster than avg
Panel avg: 113d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

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 57
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K172903.
INNOVANCE® D-Dimer 2.0 (SMN 10873803)
K253985 · Siemens Healthcare Diagnostic Products GmbH · Aug 2026
STA® - Liatest® D-Di
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HemosIL D-Dimer HS
K160885 · Instrumentation Laboratory CO · Oct 2016
HemosIL D-Dimer HS
K151534 · Instrumentation Laboratory CO · Jul 2015
STA LIATEST D-DI
K141144 · Diagnostica-Stago · Sep 2014
VIDAS D-DIMER EXCLUSION II (DEX2)
K112818 · bioMerieux, Inc. · Jul 2012
K172903 · HemosIL D-Dimer HS 500
Download PDF FDA Summary Instrumentation Labor…