Cleared Traditional

K110303 - STRATUS CS ACUTE CARE D-DIMER

K110303 is an FDA 510(k) clearance for STRATUS CS ACUTE CARE 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 104-day FDA review.

K110303 · Siemens Healthcare Diagnostics · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
104d
Days
Class 2
Risk

K110303 is an FDA 510(k) clearance for the STRATUS CS ACUTE CARE D-DIMER. 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 May 16, 2011 after a review of 104 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 - K110303

510(k) Number K110303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2011
Decision Date May 16, 2011
Days to Decision 104 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
9d faster than avg
Panel avg: 113d · This submission: 104d
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 K110303.
HemosIL D-Dimer HS
K160885 · Instrumentation Laboratory CO · Oct 2016
HemosIL D-Dimer HS
K151534 · Instrumentation Laboratory CO · Jul 2015
VIDAS D-DIMER EXCLUSION II (DEX2)
K112818 · bioMerieux, Inc. · Jul 2012
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, MODEL OPBP09
K091916 · Siemens Healthcare Diagnostics · Oct 2009