Cleared Traditional

K091916 - INNOVANCE D-DIMER

K091916 is an FDA 510(k) clearance for INNOVANCE D-DIMER, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K091916 · Siemens Healthcare Diagnostics · Hematology device
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Oct 2009
Decision
121d
Days
Class 2
Risk

K091916 is an FDA 510(k) clearance for the INNOVANCE D-DIMER, MODEL OPBP09. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on October 29, 2009 after a review of 121 days - within the typical 510(k) review window.

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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K091916

510(k) Number K091916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date October 29, 2009
Days to Decision 121 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
8d slower than avg
Panel avg: 113d · This submission: 121d
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 44
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K091916.
STRATUS CS ACUTE CARE D-DIMER
K110303 · Siemens Healthcare Diagnostics · May 2011
INNOVANCE D-DIMER, MODEL OPBP09
K093626 · Siemens Healthcare Diagnostics · Nov 2010
HEMOSIL D-DIMER HS 500, CONTROLS
K090264 · Instrumentation Laboratory CO · Feb 2010
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