Cleared Traditional

K051597 - STRATUS CS D-DIMER

K051597 is the FDA 510(k) clearance for STRATUS CS D-DIMER by Dade Behring, Inc.. It is a Class 2 Hematology device (product code DAP) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K051597 · Dade Behring, Inc. · Hematology device
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Aug 2005
Decision
62d
Days
Class 2
Risk

K051597 is an FDA 510(k) clearance for the STRATUS CS D-DIMER. 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 August 17, 2005 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K051597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2005
Decision Date August 17, 2005
Days to Decision 62 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
51d faster than avg
Panel avg: 113d · This submission: 62d
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 K051597.
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
HEMOSIL D-DIMER HS
K050544 · Instrumentation Laboratory CO · Apr 2005
HEMOSIL D-DIMER
K050278 · Instrumentation Laboratory CO · Mar 2005
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
K042723 · Biosite Incorporated · Dec 2004