Cleared Traditional

K070927 - HEMOSIL D-DIMER HS

K070927 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 167-day FDA review.

K070927 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
167d
Days
Class 2
Risk

K070927 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 September 17, 2007 after a review of 167 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 CO devices

Submission Details

510(k) Number K070927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2007
Decision Date September 17, 2007
Days to Decision 167 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
54d slower than avg
Panel avg: 113d · This submission: 167d
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 41
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K070927.
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
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 HS
K050544 · Instrumentation Laboratory CO · Apr 2005