Cleared Traditional

K073042 - HEMOSIL D-DIMER

K073042 is an FDA 510(k) clearance for HEMOSIL D-DIMER, manufactured by Instrumentation Laboratory. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K073042 · Instrumentation Laboratory · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
276d
Days
Class 2
Risk

K073042 is an FDA 510(k) clearance for the HEMOSIL D-DIMER. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Instrumentation Laboratory (Lexington, US). The FDA issued a Cleared decision on July 31, 2008 after a review of 276 days - an extended review 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: 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 devices

FDA 510(k) Submission Details - K073042

510(k) Number K073042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2007
Decision Date July 31, 2008
Days to Decision 276 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 113d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 45
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K073042.
HEMOSIL D-DIMER HS 500, CONTROLS
K090264 · Instrumentation Laboratory CO · Feb 2010
INNOVANCE D-DIMER, MODEL OPBP09
K091916 · Siemens Healthcare Diagnostics · Oct 2009
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
K081732 · Siemens Healthcare Diagnostics · Oct 2008
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