Cleared Traditional

N-ASSAY TIA FIBRINOGEN TEST KIT (K965113) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K965113 · Crestat Diagnostics, Inc. · Hematology device
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Apr 1997
Decision
117d
Days
Class 2
Risk

K965113 is an FDA 510(k) clearance for the N-ASSAY TIA FIBRINOGEN TEST KIT. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on April 16, 1997 after a review of 117 days - within the typical 510(k) review window.

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: 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 Crestat Diagnostics, Inc. devices

Submission Details

510(k) Number K965113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date April 16, 1997
Days to Decision 117 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 113d · This submission: 117d
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 27
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K965113.
HemosIL Fibrinogen-C
K251968 · Instrumentation Laboratory (IL) Co. · Jul 2025
HEMOSIL FIBRINOGEN-C
K073367 · Instrumentation Laboratory CO · Dec 2007
DADE THROMBIN REAGENT
K050928 · Dade Behring, Inc. · Jun 2005
IL TEST FIBRINOGEN-C
K931721 · Instrumentation Laboratory CO · Aug 1993
QBC FIBRINOGEN
K920258 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1992
FIBRINOGEN ASSAY KIT
K841020 · Helena Laboratories · May 1984