Cleared Traditional

K063356 - STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK

K063356 is an FDA 510(k) clearance for STRATUS CS ACUTE CARE D-DIMER TESTPAK, manufactured by Dade Behring, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K063356

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.

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 48
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K063356.
INNOVANCE D-DIMER, MODEL OPBP09
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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