Cleared Traditional

K050928 - DADE THROMBIN REAGENT

K050928 is the FDA 510(k) clearance for DADE THROMBIN REAGENT by Dade Behring, Inc.. It is a Class 2 Hematology device (product code KQJ) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K050928 · Dade Behring, Inc. · Hematology device
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Jun 2005
Decision
76d
Days
Class 2
Risk

K050928 is an FDA 510(k) clearance for the DADE THROMBIN REAGENT. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - 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 K050928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2005
Decision Date June 29, 2005
Days to Decision 76 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
37d faster than avg
Panel avg: 113d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KQJ System, Fibrinogen Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
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 - KQJ System, Fibrinogen Determination

All 19
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K050928.
HemosIL Fibrinogen-C
K251968 · Instrumentation Laboratory (IL) Co. · Jul 2025
HEMOSIL FIBRINOGEN-C
K073367 · Instrumentation Laboratory CO · Dec 2007
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · Sigma Diagnostics, Inc. · Oct 1997
MULTIFIBREN U
K934326 · Behring Diagnostics, Inc. · Apr 1994
IL TEST FIBRINOGEN-C
K931721 · Instrumentation Laboratory CO · Aug 1993
FIBRINOGEN RID TEST KIT
K922416 · The Binding Site, Ltd. · Mar 1993