Cleared Traditional

K063356 - STRATUS CS ACUTE CARE D-DIMER TESTPAK

K063356 is the FDA 510(k) clearance for STRATUS CS ACUTE CARE D-DIMER TESTPAK by Dade Behring, Inc.. It is a Class 2 Hematology device (product code DAP) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K063356 · Dade Behring, Inc. · Hematology device
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Mar 2007
Decision
136d
Days
Class 2
Risk

K063356 is an FDA 510(k) clearance for the STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 23, 2007 after a review of 136 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K063356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2006
Decision Date March 23, 2007
Days to Decision 136 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
23d slower than avg
Panel avg: 113d · This submission: 136d
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 K063356.
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 D-DIMER
K051597 · Dade Behring, Inc. · Aug 2005
HEMOSIL D-DIMER HS
K050544 · Instrumentation Laboratory CO · Apr 2005
HEMOSIL D-DIMER
K050278 · Instrumentation Laboratory CO · Mar 2005