Cleared Traditional

K050544 - HEMOSIL D-DIMER HS

K050544 is the FDA 510(k) clearance for HEMOSIL D-DIMER HS by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code DAP) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K050544 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
55d
Days
Class 2
Risk

K050544 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 April 26, 2005 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K050544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date April 26, 2005
Days to Decision 55 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
58d faster than avg
Panel avg: 113d · This submission: 55d
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 K050544.
HEMOSIL D-DIMER HS
K070927 · Instrumentation Laboratory CO · Sep 2007
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
K063356 · Dade Behring, Inc. · Mar 2007
STRATUS CS D-DIMER
K051597 · Dade Behring, Inc. · Aug 2005
HEMOSIL D-DIMER
K050278 · Instrumentation Laboratory CO · Mar 2005
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
K033491 · Roche Diagnostics Corp. · Sep 2004
ADVANCED D-DIMER ASSAY
K041438 · Dade Behring, Inc. · Aug 2004