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
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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.

View all Instrumentation Laboratory CO devices

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

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