Cleared Special

K151534 - HemosIL D-Dimer HS

K151534 is an FDA 510(k) clearance for HemosIL D-Dimer HS, 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 28-day FDA review.

K151534 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
28d
Days
Class 2
Risk

K151534 is an FDA 510(k) clearance for the HemosIL D-Dimer HS. 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 July 6, 2015 after a review of 28 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 - K151534

510(k) Number K151534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2015
Decision Date July 06, 2015
Days to Decision 28 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
85d faster than avg
Panel avg: 113d · This submission: 28d
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 K151534.
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VIDAS D-DIMER EXCLUSION II (DEX2)
K112818 · bioMerieux, Inc. · Jul 2012
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K110303 · Siemens Healthcare Diagnostics · May 2011
K151534 · HemosIL D-Dimer HS
Download PDF FDA Summary Instrumentation Labor…